Regulatory Affairs Specialist

2 days ago

Makati City, National Capital Region, Philippines beBeeRegulatory Full time ₱800,000 - ₱1,200,000
Regulatory Affairs Specialist

This role acts as an end-to-end specialist in regulatory management of multi-regional, regional and national dossiers for assigned clusters/countries/therapeutic areas/products, both initial registration applications and ongoing lifecycle management through to product withdrawal. The successful candidate will be responsible for providing regulatory support to simple and complex regulatory activities in the assigned country/cluster.

The ideal candidate will have a strong understanding of country/cluster regulatory requirements and trends, with excellent technical aptitude and ability to quickly learn and use new software, regulations and quality standards. They will also possess advanced Microsoft Office Suite skills and familiarity with pharmaceutical organizational structures, systems, and culture.

The responsibilities of this role include:
  • Providing regulatory support to simple and complex regulatory activities in the assigned country/cluster.
  • Acting as the initial point of contact for assigned cluster/country under his/her responsibility for RIO Execution Hub Team Lead and key stakeholders.
  • Supporting numerous regulatory activities including M1 dossier components, HA query responses, tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization plans, and coordination of regulatory input for launch planning.
  • Partnering closely with Country Regulatory Strategist and Hub Submission/Dossier Managers to enable timely, high-quality submissions and sustained compliance.


Key qualifications for this role include:
  • B.S./B.Scs. degree in Pharmacy, Life Sciences, Business or Information Technology (or equivalent relevant professional experience).
  • Advanced to Fluent English language required. Multilingual skills desirable.
  • Familiarity with pharmaceutical organizational structures, systems, and culture.
  • An understanding of country/cluster regulatory requirements and trends is preferred.
  • Relevant experience within pharma, in Regulatory, quality and/or compliance fields.


This role offers an exciting opportunity to contribute to the success of our organization and develop your skills and expertise in regulatory affairs. If you are a motivated and experienced professional looking for a challenging and rewarding role, please apply now.

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