Regulatory Affairs Associate
2 weeks ago
Medical Device Regulatory Officer/Associate
PHI CORPORATION
Metro Manila
Full time
PHI Corporation is a Regulatory Affairs consulting and process outsourcing company specializing in the pharmaceutical, biotechnology, medical device, diagnostics, cosmetic, food/dietary supplement, and veterinary product industries. With a client-centric approach, we offer end-to-end regulatory solutions, including dossier conversion, GxP compliance, health authority liaising, and strategic regulatory planning. Our expertise spans diverse fields, ensuring tailored and compliant services for businesses of any size.
Join us to be part of a dynamic team committed to excellence in navigating regulatory landscapes and empowering clients for success. PHI Corporation is looking for licensed pharmacists to be one of its Regulatory Officer/Associate.
The Regulatory Officer/Associate handles the collections, coordination and preparation of documents for submission to regulatory agencies.
Qualifications:
at least 2 years in work experience
Licensed pharmacist
Willing to learn and build an expertise
Responsibilities:
- Ensure strict adherence to FDA guidelines for product registration.
- Stay abreast of evolving national and international legislation and guidelines pertinent to regulatory affairs.
- Prepare and submit license variations and renewal approvals in accordance with regulatory requirements.
- Offer strategic recommendations to the Director for Regulatory Affairs and other Directors involved in the application and renewal processes.
- Effectively manage project teams comprised of colleagues engaged in the product licensing application process.
- Establish and maintain productive liaisons with regulatory authorities; conduct presentations to convey pertinent information effectively.
These responsibilities underscore the critical role of the Regulatory Affairs Officer/Associate in ensuring compliance with regulatory frameworks, maintaining awareness of industry developments, and facilitating the successful submission and approval of product licenses. The role also involves strategic input, project management, and effective communication with regulatory authorities.
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