Regulatory Affairs Executive

 

  • Department: Regulatory Affairs
  • Reports To: Regulatory Affairs Manager
  • Location: Singapore

 

Job Objective

This position is to assist 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

  • Prepare registration dossiers for submission to regulatory authorities
  • Assist in the development of regulatory strategy for different regions in line with company needs
  • Coordinate with partners and regulatory consultants abroad to support overseas registration
  • Liaise with authorities on regulatory matters
  • Maintain product licenses’ life cycle management

Clinical trials

  • Provide regulatory inputs in clinical trials and ethics committee submission
  • Coordinate with the appropriate parties for the submission
  • Quality Assurance

  • Assist in GDP and relevant quality assurance matters
  • Miscellaneous

  • Arrange for documents notarisation and legalisation based on countries’ requirements
  • Arrange documents translation and obtain quotation for certain service etc. if needed.
  • Perform other additional related duties as assigned by your supervisor
  •  

    Key Accountabilities

    1. Assist registration dossier preparation and submission and follow-up until approval
    2. Assist in ensuring 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 2 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 in Europe, North America or 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 michelle.siguji@moleac.com

    • Cover letter
    • Resume
    • Expectations: Salary
    • Availability

    We regret that only shortlisted candidates will be notified.