Regulatory Pharmacist

We are seeking a detail-oriented Regulatory Pharmacist to join our team. The role involves ensuring that all company products comply with local and international regulatory requirements. This position is critical for maintaining product safety, quality, and efficacy while adhering to industry standards and government regulations.

Key Responsibilities:

Regulatory Compliance:

• Ensure all products comply with the rules and regulations set by the Food and Drug Administration (FDA) and other relevant authorities.
• Prepare and submit product registration and licensing documents.
• Monitor changes in regulatory requirements and update internal processes accordingly.

Documentation and Reporting:

• Maintain accurate records of regulatory submissions and approvals.
• Prepare technical dossiers, safety data, and product specifications for regulatory bodies.
• Coordinate and submit periodic reports and renewals for licenses and registrations.

Quality Assurance Support:

• Collaborate with the Quality Assurance team to ensure compliance with Good Manufacturing Practices (GMP).
• Conduct audits and inspections to ensure adherence to regulatory standards.

Advisory and Liaison:

• Act as the company's point of contact with regulatory agencies.
• Provide guidance to internal teams on regulatory and compliance matters.
• Liaise with suppliers and manufacturers to ensure the quality and compliance of raw materials and finished goods.
• Product Monitoring:
• Oversee post-market surveillance, including monitoring and reporting adverse drug reactions or product complaints.
• Ensure timely action for recalls or withdrawals, if necessary.

Qualifications:

• Licensed Pharmacist with a valid Professional Regulation Commission (PRC) license.
• Bachelor's degree in Pharmacy or a related field.
• Proven experience in regulatory affairs, preferably in the [specific industry, e.g., pharmaceutical, food, cosmetics].
• Strong knowledge of FDA regulations, GMP standards, and other relevant laws.
• Proficient in technical writing and documentation.
• Excellent attention to detail and organizational skills.
• Strong communication and interpersonal skills.

Job Types: Full-time, Permanent

Benefits:

• Additional leave
• Employee discount
• Life insurance
• Promotion to permanent employee

Ability to commute/relocate:

• Taguig: Reliably commute or planning to relocate before starting work (Preferred)

Education:

• Bachelor's (Preferred)

Experience:

• Pharmacist: 1 year (Preferred)

Language:

• English (Preferred)
• Tagalog (Preferred)

License/Certification:

• Pharmacist License (Preferred)

Work Location: In person