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Regulatory Affairs Hub Coordinator

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Regulatory Affairs Hub Coordinator

  • Location:

    Makati City

  • Sector:

    Monroe Life Sciences

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    April Cesar

  • Contact email:

    april.cesar@monroeconsulting.com.ph

  • Job ref:

    BBBH407723_1668480448

  • Published:

    19 days ago

  • Expiry date:

    2023-02-13

  • Client:

    Monroe Consulting Group


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