120 Regulatory Affairs Specialist jobs in Malaysia

Job Description

• Plan, prepare and submit product registration application (new, renewal & variation) to competent authorities in Malaysia and other countries where the company is exporting to.
• Follow up on registration applications with relevant authorities and business partners.
• Gathering, collating and evaluating a wide range of information via references and various media inclusive the internet.
• Collecting, coordinate, evaluating and compile data and documents in a variety of format.
• Liaising and negotiating with government agencies and business partners.
• Keeping abreast of local and international legislation, guidelines and practices.
• Providing advice to other departments as appropriate.

Job Requirement

• Self-discipline and sense of duty, strictly adhere to company policies, administrative procedures and code of conduct.
• Degree in pharmacy, biomedical sciences, biochemistry, biotechnology or relevant science field.
• Good interpersonal and computer skills.
• Self-motivated with strong initiative and able to work independently in a challenging environment.
• Able to prioritise and organise workload, adapting to fit the changing needs of the business.
• Able to converse in Bahasa Malaysia and English.
• Strong team-working skills and able to communicate clearly and effectively, verbally and in writing.
• Experience in product registration/ regulatory affairs and knowledge in pharmaceuticals (New Drug Product) would be an advantage

At MR DIY International, we're more than a global home improvement brand, we're a catalyst for ambitious talent ready to grow beyond borders.

With over 5,000+ stores across 14 countries globally, we offer unmatched international exposure to those looking to build a meaningful, global career. From retail operations and merchandising to strategy, tech, and supply chain. Your work here shapes how millions of customers shop every day.

The Regulatory Affairs Executive is responsible for conducting regulatory research and compliance preparation to support the entry of products into new countries. The role focuses exclusively on the pre-entry phase — identifying local regulatory requirements, import restrictions, documentation needs, and product compliance standards. Once the market is established and stabilized, all regulatory responsibilities are handed over to the operations team.

This role requires finding solutions from scratch—identifying requirements, addressing gaps, and ensuring the product can be successfully brought into the country.

Key Responsibilities:

New Market Regulatory Research

• Conduct detailed research on import regulations, product compliance, labeling, and packaging laws for new countries.
• Identify restricted or prohibited items, required certifications, language and localization requirements, and other entry conditions.
• Support HS code mapping and initial customs requirement identification for each product category.
• Collaborate with local consultants where needed to gather localized regulatory insights.

Preparation of Country Compliance Dossiers

• Compile regulatory summaries, product entry checklists, and documentation guides for each new market.
• Provide practical references and recommendations to assist decision-making by expansion, sourcing, and logistics teams.
• Evaluate and validate inputs from external consultants, ensuring accuracy and relevance.

Document Review & Pre-Import Readiness

• Support review and validation of technical documents such as SDS, COA and DoC.
• Identify documentation gaps and coordinate with internal and external stakeholders to resolve them before the first import.
• It is not necessary to know every regulation in advance, but the ability to identify issues and drive solutions is critical.

Handover After Market Stabilization

• Once the country is established and operations are stable, prepare and execute a complete handover to the product compliance team.
• Ensure all regulatory files, summaries, and contacts are transferred smoothly to support long-term management.

Regulatory Intelligence Management

• Build and maintain a regulatory reference database for each country entered.
• Track changes to regulations that may impact new market planning or first shipments.

Job Requirements:

• Degree in Science, International Business or related fields
• Some years of experience in regulatory affairs, market research, or FMCG related compliance work.
• Strong research, documentation, and analytical skills.
• Familiar with customs procedures, HS codes, and government regulatory portals.
• Able to manage multiple projects across varying product categories and deadlines.
• Proficient in Microsoft Excel and PowerPoint, and reporting.
• Fluent in both written and spoken English and Mandarin is required, as the role involves regular communication with internal stakeholders and Mandarin-speaking exporters.

What You Will Do

• Serve as the Management Representative with the responsibility and authority, maintain an effective Quality Management System (QMS), and report to top management on its effectiveness at planned management review meetings.
• Responsible for the preparation and documentation of regulatory submissions to government agencies.
• Gather information from technical and project personnel that addresses the performance of the Company's software products and medical devices.
• Ensure adequate documentation exists for software products and medical device claims and directs timely review of regulatory documents.
• Create, review, and update regulatory SOPs as needed.
• Support process improvement for regulatory affairs and quality assurance functions.
• Provide regulatory and quality assurance advice for ongoing and new projects.
• Lead product risk evaluation and management activities.
• Initiate Corrective Action Reports to management and resolution.
• Monitors FDA, MDD/MDR, HSA, and key target markets' agency laws and regulations, and provides recommendations and assistance to ensure company compliance.
• Prepare technical dossier for submission to regulatory authorities in key target markets.
• Direct certification application activities, including sending and tracking certification letters.
• Brings regulatory affairs and quality assurance questions/issues to the attention of management.
• Prepare responses to the agency's questions with good writing and communication skills.

What You Will Need To Have

• Degree in Science/Engineering or its equivalent.
• Minimum 2 years of experience in the medical device, pharmaceutical, and/or healthcare industry.
• Strong knowledge of local and international regulatory requirements, including ISO standards, FDA, MDD/MDR, and HSA regulations
• Certified Internal Auditor for ISO 9001 or Lead Auditor certification.
• Ability to work independently and deliver high-quality outcomes.

What Makes You Awesome Working With Us

• Culture: We enjoy open communication, less hierarchy, and hate office politics
• People: A group of ambitious people works together to achieve the company's objective
• Parking Subsidy: No more headaches in paying parking fees
• Medical: We do care about our employees' health and well-being
• Fully stocked in the pantry: You may fill your stomach as full as you want
• Coffee Break: Free Nespresso coffee is served in the pantry

Regulatory Project Specialist

Pharmaceutical Industry - Pfizer

1 year Contract (renewable basis)

Bangsar, Kuala Lumpur

Mon - Fri (9am - 6pm)

Salary : RM RM benefit +  1 month bonus

Summary :

The Regulatory Project Specialist is mainly responsible for regulatory affairs support related to new and in-line products within the country. The activities encompass regulatory submissions to the authorities for marketing authorization transfer, new product registration, variations, and miscellaneous application such as ad-hoc requests and permits, special exemption when required, and general product maintenance.

The Regulatory Project Specialist is expected to support expediting product commercialization by ensuring that local registration requirements are fulfilled and registration approvals are obtained in the shortest possible time.

Duties :

Regulatory Support

• Support the Head of Regulatory Affairs (GRS-I) to develop registration strategies, prioritize assignments, implement regulatory plans, adhere to local regulatory guidelines and requirements and coordinate multiple projects and activities in accordance with company's strategic objectives.
• Support submission of Marketing Authorization transfer and relevant post approval submissions.
• Support expediting product commercialization by ensuring that country's registration requirements are fulfilled and registration approvals are obtained as quickly as possible.
• Review, analyse, coordinate and provide feedback to HRS (GRS-I) in matters relating to new product submissions and post approval maintenance of products as required.
• Work in close collaboration with other stakeholders within the organization to ensure efficient and consistent execution of strategic regulatory plans across Pfizer's portfolio.
• Support Labeling and Artwork change management activities for products in responsible portfolio to ensure compliance to information and implementation timelines.
• Review and approve consumer medicine information, packaging labels, promotional material and other documentation as required for regulatory compliance, when required (if applicable).
• Provide document review in order to ensure the regulatory quality and scientific integrity of documents submitted to regulatory authorities and publications e.g. MIMS update.
• Support activities related to product licence maintenance and resolution of relevant regulatory issues.
• Support resolution of production and manufacturing issues, such as submission/negotiation strategy, sourcing issues, packaging issues, and compliance matters.
• Maintains awareness of changes to laws, regulations and requirements and keeps the other department managers informed of these changes as soon as possible.
• Support the maintenance of the relevant record and Pfizer Systems while ensuring timely updates as governed by the SOP.
• Provides oversight and monthly report of activities associated with the approval of a product including such activities as development and coordination of responses to Regulatory Authority inquiries, monitoring and informing with respect to product filings, approvals and launches and track performance against agreed timelines and budget.
• Provide administrative and strategic support for Poison License and Clinical trial maintenance activities (where applicable).

Communication

• Ensure effective communication and collaboration with stakeholders and other function leads (e.g. GCMC, RegOps, PGS, Commercial, Medical etc.).
• Interact and participate in negotiation discussions on regulatory matters concerning Pfizer's portfolio/interest and also involve in relationship building with Regulatory Authorities and Industry Associations, as appropriate.
• Participate in and promote team building and provide a stimulating environment which encourages team and individual growth.

Inventory Support

• Support HRS (GRS-I) in coordinating with PGS (and other relevant stakeholders), to ensure stock availability to local market, while strategically planning the timing to ensure stocks availability for new product launches.

Marketing Support

• Support the development/review of promotional materials that are in keeping with Pfizer's standards by providing the latest labeling information and strategizing product labeling to Pfizer's benefit.
• Provide regulatory input to HRS (GRS-I) to support marketing plans, product launches, and other cross-functional activities.

Regulatory Compliance

• Be accountable for regulatory compliance (of records and systems) within the area of responsibilities.
• Complete relevant training activities and comply with relevant standards in the local office to ensure compliance to local, and international regulations and Pfizer SOPs.
• Support HRS (GRS-I) to ensure registered products are fully compliant with all relevant legislation and SOP procedures.
• Coordinate with HRS (GRS-I) on product recall activities with sales, marketing, logistic and distributor which may be required by manufacturer or Regulatory Authority.

Skills

• Bachelor's degree in Science or Pharmacy(Pharmacist degree may be mandatory in some countries)
• Preferably 1 year of working experience in a regulatory affairs environment
• Fluent in English written and spoken communication skills
• Good knowledge of international or local regulatory guidelines and codes
• Preferably with knowledge across multiple therapeutic areas
• Meticulous nature and proficient in data tracking and consolidation
• Proven ability to consistently deliver to time, cost, and quality standards.
• Ability to effectively deliver in a complex matrix environment.

What You Will Do

• Serve as the Management Representative with the responsibility and authority, maintain an effective Quality Management System (QMS), and report to top management on its effectiveness at planned management review meetings.
• Responsible for the preparation and documentation of regulatory submissions to government agencies.
• Gather information from technical and project personnel that addresses the performance of the Company's software products and medical devices.
• Ensure adequate documentation exists for software products and medical device claims and directs timely review of regulatory documents.
• Create, review, and update regulatory SOPs as needed.
• Support process improvement for regulatory affairs and quality assurance functions.
• Provide regulatory and quality assurance advice for ongoing and new projects.
• Lead product risk evaluation and management activities.
• Initiate Corrective Action Reports to management and resolution.
• Monitors FDA, MDD/MDR, HSA, and key target markets' agency laws and regulations, and provides recommendations and assistance to ensure company compliance.
• Prepare technical dossier for submission to regulatory authorities in key target markets.
• Direct certification application activities, including sending and tracking certification letters.
• Brings regulatory affairs and quality assurance questions/issues to the attention of management.
• Prepare responses to the agency's questions with good writing and communication skills.

What You Will Need To Have

• Degree in Science/Engineering or its equivalent.
• Minimum 2 years of experience in the medical device, pharmaceutical, and/or healthcare industry.
• Strong knowledge of local and international regulatory requirements, including ISO standards, FDA, MDD/MDR, and HSA regulations
• Certified Internal Auditor for ISO 9001 or Lead Auditor certification.
• Ability to work independently and deliver high-quality outcomes.

What Makes You Awesome Working With Us

• Culture: We enjoy open communication, less hierarchy, and hate office politics
• People: A group of ambitious people works together to achieve the company's objective
• Parking Subsidy: No more headaches in paying parking fees
• Medical: We do care about our employees' health and well-being
• Fully stocked in the pantry: You may fill your stomach as full as you want
• Coffee Break: Free Nespresso coffee is served in the pantry

Key Responsibilities/ Key Activities:

• Regularly prepares, approves and issues labelling specifications to meet business needs and timelines for the local and foreign markets by following and using effectively JDE & SARA agreed processes and tools.
• Conducts accurate label compliance reviews, such as proposing legal designations and acceptable claims wording, considering local Business requests and legal feedback.
• Provides legal and accurate ingredients line and nutrition data for food product labels.
• Assures implementation of correct graphic design, and able to advise and guide team members on artwork design elements.
• Assures implementation of correct techno-legal label information and JDE standards, e.g. allergen labelling and claims.
• Provides regulatory guidance on compositional requirements to R&D, e.g. checks for acceptable ingredients and their legal limits in recipes.
• Timely reviews and approves new raw materials and product specifications for regulatory compliance in local and other countries, including checking product recipes, nutrition data and allergens information.
• Create and review product specifications based on internal specification guidelines.
• Represents JDE as an expert on local industry associations, scientific institutions and governmental bodies in collaboration with SARA team leads and/or R&D Lead. Identifies, Head of Department and stays abreast of emerging scientific issues and legislation changes.
• Interacts regularly with the other R&D team members, and in particular functional manager, on weekly deliverables.

Are you bursting with fresh ideas and a hunger for learning? We want you!

Here's what we're looking for:

• Academic Program : Degree or Master in Nutrition, Food Chemistry, Food Technology, Food Science or equivalent.
• Experienced : Minimum at 3 to 5 years’ experience in related field.
• Skillset : Possess Knowledge of (EU) food legislation, understanding of nutrition science and food safety, product development, ingredients, manufacturing and business processes.
• Personal traits : You have a structured approach, a driven and energetic personality, excellent communication and people skills, and the ability to work both in a team and independently.

Here's how to apply:

• Upload your resume (in English) using our LinkedIn or career site application form
• After applying, we'll reach out within three weeks to let you know what's next.
• During the application process, you'll be asked to do an online assessment and at least one interview at our Johor office.

For more than 265 years, JACOBS DOUWE EGBERTS (JDE) is inspired by its belief that it’s amazing what can happen over a cup of coffee or tea. We are fuelled by our purpose of unleashing the possibilities of coffee and tea to create a better future. Today, our coffee & tea portfolio is available in more than 100 developed and emerging markets, through a portfolio of over 50 brands that collectively cover the entire category landscape led by leading household names such as L’OR, Jacobs, Senseo, Tassimo, Douwe Egberts, Old Town, Super, Pickwick and Moccona.

JDE is part of JDE Peet’s, the world’s largest pure-play coffee and tea company, headquartered in The Netherlands.

What’s it like to work at JDE?

We are proud of our passionate, driven associates that challenge the status quo and pursue mastery in everything they do. Our goal is simple and ambitious – JDE: A coffee & tea for every cup.

At JDE, we're Made to Stand Out. Every day we are progressive in outlook, ambitious in nature, resourceful in action and decisive in approach, bringing coffee and tea moments to everyone around the world.

Key Responsibilities/ Key Activities:

• Regularly prepares, approves and issues labelling specifications to meet business needs and timelines for the local and foreign markets by following and using effectively JDE & SARA agreed processes and tools.
• Conducts accurate label compliance reviews, such as proposing legal designations and acceptable claims wording, considering local Business requests and legal feedback.
• Provides legal and accurate ingredients line and nutrition data for food product labels.
• Assures implementation of correct graphic design, and able to advise and guide team members on artwork design elements.
• Assures implementation of correct techno-legal label information and JDE standards, e.g. allergen labelling and claims.
• Provides regulatory guidance on compositional requirements to R&D, e.g. checks for acceptable ingredients and their legal limits in recipes.
• Timely reviews and approves new raw materials and product specifications for regulatory compliance in local and other countries, including checking product recipes, nutrition data and allergens information.
• Create and review product specifications based on internal specification guidelines.
• Represents JDE as an expert on local industry associations, scientific institutions and governmental bodies in collaboration with SARA team leads and/or R&D Lead. Identifies, Head of Department and stays abreast of emerging scientific issues and legislation changes.
• Interacts regularly with the other R&D team members, and in particular functional manager, on weekly deliverables.

Are you bursting with fresh ideas and a hunger for learning? We want you!

Here's what we're looking for:

• Academic Program : Degree or Master in Nutrition, Food Chemistry, Food Technology, Food Science or equivalent.
• Experienced : Minimum at 3 to 5 years’ experience in related field.
• Skillset : Possess Knowledge of (EU) food legislation, understanding of nutrition science and food safety, product development, ingredients, manufacturing and business processes.
• Personal traits : You have a structured approach, a driven and energetic personality, excellent communication and people skills, and the ability to work both in a team and independently.

Are you ready to Unleash Your Possibility within JDE Peet's?

Here's how to apply:

• Upload your resume (in English) using our LinkedIn or career site application form.
• After applying, we'll reach out within three weeks to let you know what's next.
• During the application process, you'll be asked to do an online assessment and at least one interview at our Johor office.

Would you like to join a Coffee & Tea company that values your future success and prioritizes your passion for positive change?

Here’s why you should apply:

• Passionate, energetic & innovative work culture.
• Exciting allowances to perk up your day.
• Sports perks to keep you energized.
• The best coffee and tea served all day in our office – or be your own Barista!

For more than 265 years, JACOBS DOUWE EGBERTS (JDE) is inspired by its belief that it’s amazing what can happen over a cup of coffee or tea. We are fuelled by our purpose of unleashing the possibilities of coffee and tea to create a better future. Today, our coffee & tea portfolio is available in more than 100 developed and emerging markets, through a portfolio of over 50 brands that collectively cover the entire category landscape led by leading household names such as L’OR, Jacobs, Senseo, Tassimo, Douwe Egberts, Old Town, Super, Pickwick and Moccona.

JDE is part of JDE Peet’s, the world’s largest pure-play coffee and tea company, headquartered in The Netherlands.

What’s it like to work at JDE?

We are proud of our passionate, driven associates that challenge the status quo and pursue mastery in everything they do. Our goal is simple and ambitious – JDE: A coffee & tea for every cup.

At JDE, we're Made to Stand Out. Every day we are progressive in outlook, ambitious in nature, resourceful in action and decisive in approach, bringing coffee and tea moments to everyone around the world.

Reports to: Director, Regulatory Affairs

Location: Petaling Jaya, Malaysia

The Company

AbbVie (NYSE:ABBV) AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

PRIMARY FUNCTION/OBJECTIVE

The Regulatory Affairs Department obtains and maintains marketing approvals of responsible Abbvie produc ts in Malaysia, Brunei and Indonesia. It ensures full local regulatory and company compliance, and provides r egulatory expertise to support clinical research, product launches, business development so as to assist achie ving business growth and full compliance with legal requirements for pharmacovigilance regarding regul atory affairs relevant responsibilities

The position is to handle preparation of regulatory submissions in order to obtain and maintain marketing ap provals of company products for the assigned therapeutic areas and countries, and to provide advice on regu latory matters to staff and customers.

CORE JOB RESPONSIBILITIES

• Manage registration of new products and variations to marketed products (including medical devices) to ensure regulatory approvals are achieved in accordance with company objectives.
• Ensure new product registrations and approval maintenance is conducted in a timely manner according to the registration plan.
• Report progress and status to manager and superior management as required including to corporate RA and Brand Team meetings.
• Develop checklist and streamline processes to increase productivity.
• Coordinate responses to deficiency letters and other requests for data from regulatory authorities for products and ensure it meets agreed or required timelines.
• Liaise with officials of Government agencies to facilitate evaluation processes and respond to requests for data in agreed timelines.
• Review labeling, over-labeling, product information to ensure compliance with relevant regulations and codes. Update product labeling in a timely manner based on the update of the product labeling from headquarters.
• Communicate regulatory issues and important changes and evaluate the impact on the business to manager and Business Unit.
• Maintain good knowledge of relevant corporate policies and local regulations and ensure compliance. Keep abreast of regulatory changes and evaluate the impacts on the business and communicate changes in a timely manner to related parties and management.
• Update RA SOPs when regulations and processes are updated and review them to ensure they are within the validity timeframe.
• Execute registration plans and provide regular status reports.
• Other regulatory projects and tasks assigned by RA head.

PREFERRED QUALIFICATIONS

• University degree in Pharmacy, Pharmacology or related disciplines
• Minimum 3-4 years of experience and in-depth knowledge of regulatory requirements in new drug applications for NCEs and Medical Device application in Malaysia. Experience managing Indonesia wil l be good advantage.
• Strong communications and coordination skills
• Proficiency in communicating strategic and tactical issues to management
• Proven interpersonal skills

Code of Conduct & Business Integrity

AbbVie is committed to observe high integrity and ethical standards in all its business dealings with our customers, with each other, business partners and suppliers.

AbbVie as a responsible corporate citizen will adhere to these standards, as well as to local, national and international laws.

All AbbVie employees are responsible for maintaining the Company's reputation for conduct in accordance with the highest level of business integrity, ethics and compliance with the law. Soliciting and/or accepting/attempting/offering bribes or any illegal gratification is therefore cause for immediate dismissal.

Candidate is therefore required to maintain the highest ethical standards in his conduct of Company affairs at all times and uphold the AbbVie Values.