Regulatory Affairs Associate

2 days ago

Caloocan City Central Post Office, Philippines Lifestrong Marketing Full time ₱600,000 - ₱1,200,000 per year

Duties and Responsibilities

Regulatory Submissions & Filings

  • Support in preparing and submitting regulatory documents, including applications for product registrations, licenses, and other approvals required by the FDA Philippines and related agencies.
  • Draft and review dossiers for product registration, renewals, variations, and other filings.
  • Monitor submission timelines, track progress, and ensure timely completion of all regulatory requirements.

Regulatory Compliance & Advisory

  • Provide guidance to internal teams (R&D, manufacturing, quality control) to ensure compliance with local regulatory standards.
  • Review product labeling, advertising, and promotional materials to confirm alignment with Philippine regulations.
  • Stay informed on changes in laws and regulatory guidelines; update internal stakeholders on new or revised requirements.

Communication with Authorities

  • Act as the company's liaison with FDA Philippines, DOH, and other government agencies.
  • Assist in preparing responses to agency queries and follow up on pending submissions.
  • Support the team during audits, inspections, and regulatory evaluations.

Post-Market Surveillance

  • Assist in monitoring product compliance after launch through post-market surveillance activities.
  • Help prepare required reports such as Adverse Event Reports (AERs), Periodic Safety Update Reports (PSURs), and others.
  • Support product recall activities when necessary, ensuring compliance with regulatory procedures.

Documentation & Records Management

  • Maintain well-organized records of regulatory submissions, approvals, and communications.
  • Ensure documents are updated and readily available for audits or inspections.
  • Keep detailed logs of company interactions with FDA Philippines and other authorities.

Regulatory Research & Market Insights

  • Track local regulatory updates, trends, and industry developments to support compliance.
  • Research and analyze requirements for new products, market expansions, or product changes.

Cross-Functional Collaboration

  • Work closely with legal, marketing, R&D, and manufacturing teams to align product development and marketing with regulations.
  • Contribute to the development of regulatory strategies for new products, ensuring compliance from early stages.

Qualifications

  • Bachelor's Degree in Pharmacy (required).
  • 1–2 years of experience in Regulatory Affairs or Quality Assurance.
  • Strong knowledge of FDA Philippines regulations and cosmetic product registration.

Job Type: Full-time

Benefits:

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

Education:

  • Bachelor's (Preferred)

Experience:

  • Regulatory Affairs Associate: 1 year (Preferred)

License/Certification:

  • Licensed Pharmacist (Preferred)

Work Location: In person

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