Regulatory Affairs Hub Coordinator

  • Sector: 生命科学
  • Contact: April Cesar
  • Client: Monroe Consulting Group
  • Location: Makati City
  • Salary: Negotiable
  • Expiry Date: 13 February 2023
  • Job Ref: BBBH407723_1668480448
  • Contact Email:

Executive recruitment company Monroe Consulting Group Philippines is recruiting on behalf of leading provider of regulatory digital compliance products and software validation & testing services for the life sciences industry. Our respected client is currently seeking a Regulatory Affairs Hub Coordinator. This is based in Makati City, currently in a WFH setup.

Key Job Responsibilities:

  • Participation in regulatory processes to gain and maintain APAC and non-APAC marketing authorizations for human and veterinary medicinal products (application, renewal, variations)
  • General guidance (consultancy) of staff and customers regarding Regulatory Submissions & Labeling
  • Participation in the preparation and revision and compilation of the informative texts for healthcare professionals and patients (SmPC, PIL, Labeling)
  • Presenting seminars and lectures internally, for customers and for professional audience
  • Responsible for the planning, filing and prosecution of approval projects.
  • Creation, revision, editing and maintenance of regulatory documentation.
  • Planning and expediting the approval projects using the internally available or client-based software tools (Veeva Vault).
  • Communication with the client and the Health Authorities (APAC region).
  • Coordination of project teams with internal and external staff and RegNet Partners.
  • Contribution to optimizing departmental internal/clients processes.
  • Active contribution and distribution of department relevant expertise.

Key Job Qualifications:

  • Graduate of BS Pharmacy, Chemistry, Biochemistry, Microbiology or other natural sciences
  • At least 4 years of experience in evaluation, preparation, and compilation of quality documentations and/or experience in regulatory processes and quality aspects
  • Leadership experience with direct reports