Senior Regulatory Affairs Specialist

3 weeks ago

Pasig, Philippines Getz Pharma Philippines Full time

At Getz Pharma, our mission is to make a global impact by developing and delivering safe, effective, and high-quality medicines that improve the lives of men, women, and children.

Be part of a company where your work directly contributes to better health outcomes and a healthier world.

Why Join Getz Pharma as a Senior Regulatory Affairs Specialist? Drive Regulatory Excellence and Compliance
  • Lead the preparation, review, and submission of regulatory dossiers for product registrations, variations, and renewals.
  • Act as the primary liaison with the FDA and other health authorities, ensuring timely responses and positive relationships.
  • Monitor evolving regulatory guidelines and communicate their impact to internal stakeholders.
Support Cross-Functional Teams to Deliver Better Medicines
  • Provide regulatory guidance to R&D, Quality, Supply Chain, Marketing, and Medical Affairs teams.
  • Ensure product labeling, promotional materials, and packaging meet all regulatory requirements.
  • Collaborate across departments to integrate regulatory strategies into product development and lifecycle management.
Lead Regulatory Strategy and Product Lifecycle Management
  • Drive regulatory strategy for assigned products to achieve timely approvals.
  • Ensure product registrations are maintained and renewed without disruption.
  • Participate in audits and inspections, ensuring compliance with both local and international standards.
Mentor and Share Expertise
  • Guide and train junior Regulatory Affairs team members on processes, best practices, and compliance.
  • Share insights on regulatory updates and industry trends to strengthen team capability.
  • Take ownership of additional responsibilities in a dynamic, fast-paced environment.
Qualifications
  • Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or related field (Master’s degree preferred).
  • 4-5 years of regulatory affairs experience in the pharmaceutical industry.
  • Strong knowledge of FDA, ASEAN, and ICH guidelines.
  • Proven experience in preparing and submitting regulatory dossiers.
  • Excellent communication, project management, and organizational skills.
  • Ability to work cross-functionally and manage multiple priorities.
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