What Jobs are available for Regulatory Consulting Firms in Malaysia?

**The Position** ** **
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.

Cargill's size and scale allows us to make a positive impact in the world. Our purpose is to nourish the world in a safe, responsible and sustainable way.
Cargill is a family company providing food, ingredients, agricultural solutions and industrial products that are vital for living. We connect farmers with markets so they can prosper. We connect customers with ingredients so they can make meals people love. And we connect families with daily essentials - from eggs to edible oils, salt to skincare, feed to alternative fuel. Our 160,000 colleagues, operating in 70 countries, make essential products that touch billions of lives each day. Join us and reach your higher purpose at Cargill.
This position is in Cargill's food and bioindustrial business, where manufacturers, retailers, and foodservice companies rely on us to consistently deliver the products and services they need, and use our technical expertise and market knowledge to develop innovative products.
**Job Purpose and Impact**
The Country Regulatory and Scientific Affairs Lead will ensure compliance with government regulations or standards in the areas of labeling, registration, customer documentation, permitting, licensing and other regulatory functions. in this role you will provide technical support to sales, customers, operations and government agencies in regulatory functions.
**Key Accountabilities**
+ Understand regulations and changes, assess risk and opportunities and ensure compliance in a variety of methods, related to labeling, registration, customer documentation, permitting, licensing and other regulatory functions.
+ Review proposed laws, procedural changes and regulations to resolve potential impact within business.
+ Develop and implement programs, processes and documentation to resolve regulatory issues working with external trade associations.
+ Provide internal training and consultation on complex regulatory or compliance topics.
+ Independently gather, analyze, and implement programs, processes and documentation.
+ Independently solve moderately complex issues with minimal supervision, while escalating more complex issues to appropriate staff.
+ Other duties as assigned
**Qualifications**
**Minimum Qualifications**
+ Bachelor's degree in a related field or equivalent experience
+ Advanced computer skills using email, spreadsheet, presentation and word processing applications
+ Minimum of five years of related work experience
+ Other minimum qualifications may apply
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