Regulatory Affairs Professional

1 week ago

Taguig, National Capital Region, Philippines beBeeRegulatory Full time ₱600,000 - ₱1,200,000
Regulatory Affairs Expert

The primary responsibility of this role is to apply in-depth knowledge in the area of Regulatory Affairs as an experienced professional individual contributor.

This requires the ability to apply skills and knowledge within the context of specific needs or requirements, working under limited supervision.

Key Responsibilities:
  • Direct the development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports, utilizing well-developed skills in Regulatory Affairs.
  • Interact with regulatory agencies to expedite approval of pending registrations.
  • Serve as a regulatory liaison throughout the product lifecycle.
  • Participate in product plan development and implementation, regulatory strategy, risk management, and chemistry manufacturing control (CMC).
  • Ensure timely approval of new drugs, biologics, or medical devices and continued approval of marketed products.
  • Serve as a regulatory representative to marketing, research teams, and regulatory agencies.
  • Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations.
Qualifications:
  • Associate Degree required
  • Minimum 1 year of experience in Regulatory Affairs

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