Regulatory Affairs Pharmacist

5 days ago

Caloocan City, National Capital Region, Philippines Lifestrong Marketing Full time ₱900,000 - ₱1,200,000 per year

1. Regulatory Submissions and Filings

  • Prepare and submit regulatory documents for product registration, renewals, variations, and licensing as required by the FDA Philippines and other regulatory agencies.

2. Regulatory Compliance and Guidance

  • Provide regulatory guidance to cross-functional teams (e.g., R&D, QC, manufacturing) to ensure products and processes comply with Philippine regulatory requirements.
  • Review product labels, advertisements, and promotional materials for regulatory compliance.
  • Monitor and interpret changes in Philippine regulatory laws, standards, and guidelines, and communicate updates to relevant stakeholders.

3. Communication with Regulatory Authorities

  • Serve as the point of contact between the company and regulatory bodies such as FDA Philippines, DOH, and other local agencies.
  • Prepare and submit responses to regulatory queries, deficiencies, and requests for additional information.
  • Support regulatory inspections and audits, including the preparation of documentation and onsite coordination.

4. Post-Market Surveillance and Compliance

  • Participate in post-market activities including monitoring for adverse events, safety reporting, and regulatory updates.
  • Coordinate and submit Adverse Event Reports (AERs), Periodic Safety Update Reports (PSURs), and other post-approval documentation.
  • Support product recall activities in compliance with FDA Philippines requirements.

5. Documentation and Record Keeping

  • Maintain up-to-date records of all regulatory submissions, approvals, and correspondences.
  • Ensure regulatory documentation is audit-ready and stored according to compliance and company policies.
  • Keep a detailed log of all interactions and communications with regulatory authorities.

6. Market Intelligence and Regulatory Research

  • Continuously monitor the local regulatory landscape, including emerging regulations, policies, and enforcement trends.
  • Conduct regulatory assessments for new product introductions or market expansions.
  • Provide recommendations based on current and anticipated regulatory requirements.

7. Cross-functional Collaboration

  • Work closely with internal teams including Legal, Marketing, R&D, QA/QC, and Manufacturing to ensure regulatory considerations are integrated throughout the product lifecycle.
  • Contribute to the development of regulatory strategies for new and existing products, starting from early development through commercialization.
  • Ensure completeness, accuracy, and timeliness of regulatory dossiers and filings.
  • Track submission timelines and monitor the progress of applications to ensure timely approvals.

Job Types: Full-time, Permanent

Benefits:

  • Company Christmas gift
  • Company events
  • Employee discount
  • Opportunities for promotion
  • Paid training
  • Promotion to permanent employee

Work Location: In person

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