Regulatory Affairs Specialist – (APAC & RoW)

Key Responsibilities :

Regulatory Submissions & Compliance

Author, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others.

Conduct dossier gap analysis to identify document and data gaps across all CTD modules (1–5).

Convert and prepare dossiers in multiple formats including eCTD, ACTD, and CTD.

Manage end-to-end preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions (variations, renewals, withdrawals).

Coordinate responses to health authority queries through cross-functional collaboration and data collation.

Maintain a strong command over CMC, clinical, non-clinical, and administrative documentation to ensure successful global submissions.

Project Planning & Management

Manage regulatory submissions for multiple products across multiple countries simultaneously.

Utilize project management tools to track project milestones, timelines, and deliverables.

Ensure efficient time and resource allocation to meet submission deadlines.

Foster seamless communication between central regulatory, regional teams, and client stakeholders.

Requirements :

8–10 years of core experience in Regulatory Affairs , handling submissions across regulated and RoW markets .

Strong understanding of global dossier formats, submission pathways, and lifecycle management.

Excellent cross-functional communication and coordination skills.

Proven ability to manage complex multi-country regulatory portfolios.