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