Regulatory Affairs Pharmacist

5 days ago

Caloocan City, National Capital Region, Philippines Lifestrong Marketing Full time $104,000 - $130,878 per year

Duties and Responsibilities

  • Regulatory Submissions and Filings:
  • Assist in the preparation and submission of regulatory documents, including applications for product registration, licenses, and other regulatory approvals required by the FDA Philippines and other relevant agencies.
  • Prepare and review regulatory dossiers for product registrations, renewals, variations, and other regulatory filings.
  • Monitor the progress of product submissions and track submission deadlines to ensure timely filings.
  • Regulatory Compliance and Guidance:
  • Provide regulatory advice to internal teams (e.g., R&D, manufacturing, quality control) to ensure product development and manufacturing processes comply with local regulations.
  • Ensure that the company's products, labeling, advertising, and promotional materials meet Philippine regulatory requirements.
  • Monitor changes in regulatory laws and guidelines in the Philippines and update internal teams on new or revised requirements.
  • Communication with Regulatory Authorities:
  • Act as a liaison between the company and local regulatory authorities, including the FDA Philippines, Department of Health (DOH), and other relevant government bodies.
  • Assist in preparing responses to queries or requests from regulatory agencies and handle follow-up on submissions.
  • Support the regulatory team during audits or inspections by regulatory authorities.
  • Post-Market Surveillance and Compliance:
  • Assist in post-market surveillance activities, ensuring products remain compliant after launch in the market.
  • Coordinate the preparation of periodic reports, including Adverse Event Reports (AERs), Periodic Safety Update Reports (PSURs), and other required documentation.
  • Support activities related to product recalls, if necessary, and ensure compliance with the regulatory authorities' requirements for recall procedures.
  • Documentation and Record Keeping:
  • Maintain accurate and organized records of regulatory submissions, correspondence, and approvals.
  • Assist in ensuring that regulatory documents are updated and accessible for audits, inspections, and regulatory compliance reviews.
  • Keep detailed records of the company's interactions with the FDA Philippines and other regulatory bodies.
  • Market Intelligence and Regulatory Research:
  • Stay updated on local regulatory changes, trends, and industry news to ensure the company remains compliant with evolving regulations.
  • Research and analyze local regulatory requirements for new products, product changes, or market expansions.
  • Cross-functional Collaboration:
  • Work closely with internal departments such as legal, marketing, R&D, and manufacturing to ensure that products are developed, produced, and marketed in compliance with regulatory standards.
  • Assist in the preparation of regulatory strategies for new products, ensuring adherence to local regulations from the early stages of development.

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 Pharmacist: 1 year (Preferred)

Language:

  • English (Preferred)

Work Location: In person

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