Manager, Regulatory Affairs

MSD

Petaling Jaya, Selangor
Permanent
Full-time

25 days ago

Job DescriptionManager, Regulatory Affairs

Based in Malaysia, named one of the Best Companies to Work for in 2019 by HR Asia
Join the premier biopharmaceutical company that has been in the business for more than 25 years and in AP for over 60 years.

Key Responsibilities:

Develop and implement regulatory strategy to accelerate products and indications pipeline
Drive regulatory policy shaping initiatives with local regulatory agency, trade association and other external stakeholders.
Ensure regulatory support through product life cycle including labelling, CMC and dossier modifications
Coordinate the preparation of post-approval regulatory documents in accordance with agreed timeframes
Lead/participate in negotiations during regulatory approval processes for applications with the regulatory agencies
Participate in inter-company organizations focusing on specific industry-related issues
Keep abreast on all regulatory requirements (local, ASEAN, ICH, WHO), market, and industry developments
Build long term effective relationships and keeps open communication with Regional / Global colleagues
Monitor regulatory agencies and industry changes, trends and requirements to contribute effectively to product development and regulatory strategies
Cooperate with other departments to collect information needed for recall reporting, including initial and follow-up reports, and others
Contribute with regulatory support during health authority site inspections
Attend inter-departmental meetings discussing product issues and priorities to develop clear and concise plans with milestones to reach the desired outcomes
Participate in development of regulatory strategies for product changes, to ensure compliance with the current regulatory requirements
Participate in working and industry groups to provide input to shape the regulatory landscape and maintain prospective awareness of evolving regulatory expectations
Serves as a local in-house CMC expert and able to provide a specialized perspective for product life-cycle management.

Education Minimum Requirement:

Graduates with Pharmacy degree or graduates with Science related degree eg BioMedical, Biochemistry, Pharmaceutical Science, Biotechnology etc.
First class honours or high second upper degree

Required Experience and Skills:

Registered pharmacist are encouraged to apply
A minimum of 10 years of relevant pharmaceutical regulatory experience, preferably with MNC background, including experience in regulatory affairs policy shaping and CMC
Ability to communicate well verbally and in writing to internal and external stakeholders is essential
Detail oriented, meticulous and organized
Has basic IT knowledge
Able to work within targeted timelines
Advanced project management skills
Self-motivated and strong commitment to achieve desired results and right first time
Team player

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Current Employees applyCurrent Contingent Workers applySearch Firm Representatives Please Read Carefully
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