Regulatory Affairs Dept. Head

17 hours ago

Calabarzon, Philippines HRTX Full time


Regulatory Affairs Department Head
Location: Laguna, On-site
Work Schedule: Monday to Friday, Morning Shift

About the Role
We are looking for an experienced and detail-oriented Regulatory Affairs Department Head to lead the Regulatory team and manage all product registration activities for both local and export markets. The role ensures full compliance with regulatory standards, oversees the preparation and submission of technical dossiers, and coordinates closely with internal departments and government agencies.  

Key Responsibilities

  • Lead and supervise a team composed of a Regulatory Affairs Manager and a Regulatory Affairs Associate.
  • Oversee the preparation, review, and submission of complete technical dossiers for regulatory applications.
  • Ensure timely renewal of product registrations, licenses, certificates, and permits.
  • Coordinate with Technical Services, Quality Control, Formulation, Marketing, and client representatives for registration requirements.
  • Liaise with local and international regulatory authorities for approvals.
  • Provide guidance to internal teams regarding regulatory requirements.
  • Maintain updated information on regulatory requirements in Asia and the Pacific.
  • Serve as the companys Pharmacovigilance Officer.

Qualifications

  • Bachelors Degree in Pharmacy or Industrial Pharmacy
  • Must be a licensed pharmacist
  • At least five years of experience in product registration
  • Strong understanding of regulatory processes and requirements
  • Excellent attention to detail and strong documentation and communication skills
  • Basic knowledge of GMP, ISO 9001:2015, and EHS standards

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