Associate Regulatory Affairs Manager/Regulatory Affairs Manager

 

  • Department: Regulatory Affairs
  • Reports To: Vice President, Head of Regulatory Affairs &Quality Assurance
  • Location: Singapore

 

Job Objective

This position is to manage the RA department in terms of obtaining & maintaining registration licenses for the global market, meanwhile providing necessary support in quality assurance matters.

 

Principal Responsibilities

Product registration

  1. Prepares registration dossiers for submission to authorities in international countries
  2. Technical expert in all regulatory affairs related matters of the country
  3. Coordinates with partners and regulatory consultants abroad to support overseas registration
  4. Work closely with Head of Regulatory Affairs to develop regulatory strategy for different regions in line with company needs.
  5. Liaises with health authorities on regulatory matters
  6. Prepares the response or arguments for queries from the Authority within strict deadline
  7. Maintains all related product lifecycle management activities and following up on product approval commitments
  8. Prepare regional registration dossiers (eg. International Common Technical Document (ICTD) and ASEAN Common Technical Document (ACTD)
  9. Perform regulatory feasibility for new country submissions
  10. Prepares IND for USFDA submission for product under development stage (Phase II,III)

Clinical trials

  1. Provide regulatory inputs in clinical trials and ethics committee submission
  2. Coordinate with the appropriate parties for the submission

Quality Assurance

  1. Assist in GDP and relevant quality assurance matters

Miscellaneous

  • Mentor and guide new RA staff
  • Perform other additional related duties or assignments from the management
  • Involve in local industry association meetings

 

Key Accountabilities

  1. Perform registration dossier preparation and submission and follow-up until approval
  2. Ensure compliance to all relevant requirements pertaining to regulatory and quality so as to maintain continuous business activities.

 

Relevant Experience

  1. The ideal candidate should preferably have at least 5-7 years of regulatory affairs working experience.
  2. Knowledge in international regulatory guidelines such as ICH, ASEAN, USFDA, EU etc,, regulatory experience with food supplement/herbal medicine/pharmaceutical in Europe, North America, Middle East, African countries, Asia Pacific would be a plus.
  3. Good understanding in GMP, GDP and relevant quality management systems will be an added advantage.

 

Functional / Technical / Core Competencies

  1. Excellent proficiency in English (both written and spoken). Additional language such as Mandarin is a strong plus to liaise with external CMOs and partners.
  2. Independent worker and self-starter with an innovative and process driven view on regulatory affairs activities in line with business development.
  3. Good team player
  4. Good time management skill

 

Education and Professional Qualification

  1. The ideal candidate should at least hold a degree in life sciences

 

Application process:

Please send the followings to foongmei.hui@moleac.com

  • Cover letter
  • Resume
  • Expectations: Salary
  • Availability

We regret that only shortlisted candidates will be notified.