What Jobs are available for Pharmaceutical in Malaysia?
Showing 4 Pharmaceutical jobs in Malaysia
Regulatory Affairs Manager, MSI
Posted 16 days ago
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Job Description
This role is responsible for leading timely and successful product registrations in alignment with both corporate objectives and local regulatory requirements. It plays a critical part in ensuring full compliance with applicable laws, guidelines, and industry standards governing the importation, licensing, and control of therapeutic products.
You are require to collaborate with internal stakeholders and health authorities to navigate regulatory pathways efficiently and effectively. In addition to managing submissions and approvals, the role contributes strategic input to regulatory planning, supports cross-functional initiatives, and helps shape local regulatory strategies that enable market access and long-term business sustainability.
**Duties and Responsibilities:** ** **
1. Regulatory Planning and Submission Strategy
+ Manage all regulatory tasks and projects, including obtaining and maintaining product and operational licenses for the assigned portfolio on behalf of BI, as required by local regulations.
+ Prepare and submit regulatory applications for the assigned portfolio, ensuring timely approvals.
+ Develop local registration plans in alignment with local business objectives and global regulatory strategy.
+ Monitor the progress of submissions and coordinate timely responses to all questions from health authorities for the assigned portfolio.
+ Ensure compliance with corporate policies, regulations, and procedures, particularly the implementation of the current Company Core Data Sheet (CCDS), Change Review Committee (CRC), and local change control procedures.
+ Manage regulatory submissions to support clinical trial activities in the OPU, if applicable.
2. Regulatory Intelligence and Interaction
+ Keep the local Regulatory Affairs (RA) team and ROPU informed of new regulations or updates.
+ Ensure timely regulatory impact assessments.
+ Maintain close relationships with relevant health authorities and other organizations/key stakeholders to facilitate and develop effective collaboration on regulatory interactions.
+ Communicate with health authorities and local industry groups on regulatory issues.
3. Cross-Functional Collaboration and Support
+ Provide regulatory consultation and collaborate with local business stakeholders
+ Ensure that product promotion in the market complies with local and global regulatory frameworks to sustain and expand the business
+ Participate in the promotional material approval process to ensure regulatory compliance
+ Provide feedback to global teams and participate in global initiatives when required
4. Quality and Compliance
+ Ensure timely submission of CCDS updates, CRC changes, renewals, PSURs, and other local variations in compliance with internal KPIs
+ Maintain regulatory databases to reflect current registration status and regulatory requirements
+ Ensure that timelines for regulatory review in the e-MLR process are met and that promotional materials comply with local regulations
+ Contribute to audits, CAPA processes as appropriate, and support local inspection readiness
+ Archive local regulatory submission documents in accordance with internal standards
5. Deputy Role and Training Support to Local RA Team
+ Fulfill the responsibilities of the Head of Regulatory Affairs in their absence
+ Act as a mentor by providing guidance and actively training other team members in regulatory tasks, where appropriate
**Requirements:** ** **
+ Bachelor's degree; Degree in Pharmacy preferred
+ Over 7 years of experience in the pharmaceutical, medical device, or healthcare industry
+ Background in regulatory affairs or a related discipline is an advantage
+ Solid understanding of drug development and national regulatory procedures
+ Technical expertise in at least one therapeutic or regulatory area (e.g., CMC, clinical)
+ Proven ability to interact with health authorities and navigate local regulatory requirements
+ Strong communication skills for both internal and external stakeholders
+ Proficient in English (written and verbal)
+ Comfortable working with databases; strong computer literacy
+ Effective in cross-functional, matrix environments
+ Proactive, assertive, and collaborative team player
All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
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(WFH) Quality Assurance Executive
Posted 16 days ago
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Job Description
Join Our Alpha Iota Family, Where Everyone Wins!
Exciting Work-from-Home Opportunities
Learning & Development Programs to Upskill Yourself
Lucrative Salary Package
Health and Wellness Perks & Benefits
Motivating and Supportive Teams
.and lots more!
Alpha Iota is based in Southeast Asia , where we are rapidly growing and are constantly on the lookout for talented individuals like yourself who want to make a difference and kickstart their successful careers. Here's what awaits you at Alpha Iota!
What would you be doing:
Manage the quality assurance for the clients that Alpha Iota is serving.
Monitor Live Chats from Customer Service Executives.
Manage Alpha Iotas' clients' expectations by maintaining a good quality of internal output.
Provide coaching and follow-up coaching sessions that are adhered to.
Identify issues and areas of improvement (agent level, process, and business level), propose, approve, and track the necessary corrective action(s) to satisfactory.
Dive into service quality issues, which are inclusive of Customer Service Satisfaction, First Contact Resolution, Average Response Time, Quality Assurance Evaluation pass rate, and customer complaints.
Participate in the development and delivery of training and programme support for quality and operational needs. This includes soft skills, product, systems, and processes. You are also responsible for ensuring and monitoring the overall effectiveness of training.
Promote a culture of high performance and continuous improvement that values learning and a commitment to quality among the team.
Perform ad hoc tasks as assigned by management, ensuring timely and high-quality completion, such as supporting live customer interactions by handling chats through the live chat system when required, and maintaining professional and effective communication.
Stay aligned and updated with company policies by spending several hours each month handling customer interactions.
Conduct training sessions to equip new joiners with the necessary knowledge and skills to perform their roles effectively.
To be successful in this role, you will need to have:
Minimum Diploma, Advanced/Higher/Graduate Diploma.
At least 1 year of Quality Assurance (QA) / customer service experience in a contact centre environment or related industry.
Proficient in Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Google Workplace (Google Docs, Sheets, Drive).
Knowledge of customer service principles and practices, relevant computer applications, and administrative procedures.
Excellent analytical problem-solving ability.
Fluent in verbal and written English, Mandarin, and Bahasa Malaysia.
Possess a personal laptop/computer and a good Internet connection.
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Medical Representative - GP
Posted 16 days ago
Job Viewed
Job Description
As a Medical Representative, you will be:
+ Orchestrating for Exceptional Customer Experience - focused on implementing in-clinic and virtual execution of the Customer Engagement Model. Implement Multi Channel Cycle Plans to target Customers, meet/exceed sales targets for assigned product(s) within the allocated territory and achieve related quantitative/ qualitative field force KPIs
+ Adhering to Compliance, Code of Conduct and Policies - responsible for ensuring all company and industry compliance requirements(e.g. Pharmacovigilance) are understood, adhered to and established local compliance processes are followed
**Duties and Responsibilities:**
+ Sales Achievement in the assigned territory
+ Territory sales accountability (e.g. sales value, units, market share% etc.)
+ Ensure formulary listing and availability of BI products as required
+ Create demand/ generate prescriptions for promoted products by utilizing the available resources/tools/ channels and trained behaviours
+ Identify opportunities to grow/expand relevant customer universe for BI promoted brands
+ Plan, co-create and execute Multi Channel Cycle Plans (MCCPs) with excellence
+ Maintain an accurate and complete customer (email address, other contact info) data base in Veeva
+ Develop, validate and execute MCCPs for the allocated territory to maximize BI Business and ensure achievement of sales targets / objectives with particular focus on message execution (reach, frequency, call duration)
+ Comprehend, integrate and execute ICPs into MCCPs
+ Plan logistics to ensure execution of MCCPs and that high value customers (Gain, Build, Defend) are seen with the required Reach and Frequency, F2F and S2S
+ Locally mandated reports (e.g. competitor surveillance) are completed accurately, in full and submitted on time
+ Orchestrate Exceptional Customer Experience
+ Communicate with relevant BI customer facing roles (marketing, MSLs etc.) and work interdependently to ensure customer experience is personalized and relevant to them.
+ Proficiency in utilizing Veeva resources; Engage (scheduling, launching meetings, group calls, sharing content), Event Management (recording events), survey function (conduct surveys), FuR function (send emails)
+ Capable of assisting customers to interact with Veeva Engage across common visual conferencing platforms
+ Identify customers' preferred communication channels, directing appropriate resources (face to face calls, Veeva Engage, phone calls, follow-up emails, BI one website, webinars, OneMessage, Adobe campaigns) to fulfill the Customers' needs
+ Management/development of assigned Key Opinion Leaders (KOLs) and Coordination with relevant Medical Societies / Institutions
+ Superior Customer Engagement Capability (Knowledge & Skills)
+ Effective Knowledge depth (Disease, Clinical Trials, Product, Marketing Strategy, Competitor intelligence and Environment) to communicate confidently and competently with customers
+ Effective Customer Engagement Skill profiency (Hybrid CEM, CSM, CEM Situational, ECiP, Engaging Customers with FuE etc.).Knowledgeable across the 7 Hybrid CEM steps and 33 behaviors. Able to execute assigned Marketing strategies (e.g. messaging/ product presentations, overcoming objections etc.) within the customers' preferred communication channel
+ Digitally fluent / tech savvy, able to reliably utilize CRM/ Veeva, undertake pre-Call set-up of digital platforms (e.g. Veeva Engage)
+ Capable and confident in Presenting to Groups of customers, both face to face / screen to screen
+ Comply with local regulations, industry and the BI Code of Conduct
+ Comply with all regulations regarding interactions with healthcare professionals (HCPs), following the BI Code of Conduct
+ Take prompt and necessary actions on issues of compliance and Pharmacovigilance
+ Be a role model in compliance with local regulations, industry and the BI Code of Conduct
+ Regular Reporting
+ Locally mandated reports (e.g. competitor surveillance) are completed accurately, in full and submitted on time
**Requirements:**
+ Bachelor's degreeCompetencies required:
+ Industry and product knowledge
+ Selling skills applied across a diverse range of channels
+ Multi Channel Cycle Planning (MCCP) and execution
+ Customer Relationship Management
+ Self development / learning
+ Communication skills
+ Planning and organizing skills to collaborate with other customer facing personnel
+ IT literacy
+ Direct selling experience in healthcare industry is advantageous
All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
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Product Manager - Oncology
Posted 16 days ago
Job Viewed
Job Description
Amgen is one of the world's leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a **Product Manager - Oncology** in **Malaysia** .
**Live**
**What you will do**
As a Product Manager - Oncology, you will play a pivotal role in the development, commercialization, and lifecycle management of Amgen's oncology portfolio in Malaysia. You will be spearheading the pre-launch preparation and execution new innovative therapies and new indications. You will lead in the collaboration with cross-functional team through all stages of the product launch process, ensuring alignment with strategic goals, timelines, and regulatory requirements. This position offers a unique opportunity for individuals passionate about advancing cancer and rare disease treatment solutions in the biotechnology industry. This position requires an individual with a blend of knowledge of the healthcare and biopharmaceutical industry, strong business acumen and passion to serve patients. This position is based in commercial office in Malaysia and reports to the Oncology & Rare Disease Business Unit Head.
**Accountabilities**
+ Development and implementation of launch plans and brand strategy to ensure execution excellence launches and brand plans
+ Improves portfolio potential of in market brands
+ Lead the collaboration with the cross-functional team to ensure the benefits to patients offered by Amgen products can be optimized
+ Engage and manage KOLs and Key Accounts to build up solid connection between customers and company.
+ Effectively manage and optimize P&L across the brands and launches
+ Ensure all plans and initiatives adhere to highest level of integrity and Amgen Values
**Responsibilities**
+ Spearhead the launch strategy development for new innovative therapies, new indication and SKUs, ensuring alignment with overall business goals.
+ Drive the execution of launch plans, monitoring progress against timelines and milestones.
+ Develop and execute product strategies to drive growth and meet business goals.
+ Serve as the primary point of contact for all launch-related activities, communicating updates and progress to senior management and stakeholders.
+ Collaborate with cross-functional teams including Marketing, Sales, Medical Affairs, Regulatory, and Supply Chain to develop integrated launch plans.
+ Create marketing materials, including promotional campaigns, sales presentations, and educational materials.
+ Coordinate with external agencies and vendors to support marketing and promotional activities.
+ Stay informed about industry trends, regulatory changes, and healthcare policies that may impact product strategy and market dynamics.
+ Ensure compliance with regulatory requirements and industry standards throughout the launch process.
**Win**
**What we expect of you**
Minimum Requirements
+ Bachelor's degree in marketing, science-related degree or an equivalent
+ 5 years in marketing function in the biopharmaceutical industry
+ Strong project management skills
+ Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively across diverse teams.
+ Ability to thrive in a fast-paced, dynamic environment and adapt to changing priorities.
Preferred Requirements
+ Previous experience in Oncology
+ Participated in new product/indication activities.
+ Familiarity with market access strategies and payer dynamics
**Thrive**
**What you can expect of us**
As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
+ Vast opportunities to learn and move up and across our global organization
+ Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
+ Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Apply now
**for a career that defies imagination**
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
**careers.amgen.com**
**Equal Opportunity Statement**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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