Regulatory Affairs Specialist

Description:

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 (15).

- 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.