Global Calcium - Manager - Regulatory Affairs

- Global Calcium is seeking a Manager Regulatory Affairs with expertise in Drug Master File (DMF) & CEP filings and global regulatory submissions.

- The ideal candidate will be responsible for preparing, reviewing, and submitting regulatory dossiers in compliance with USFDA, EU, and other regulatory markets, and other global health authorities.

Key Responsibilities:

- DMF & CEP Preparation & Submission: Compile and submit Drug Master Files (DMFs) in eCTD or NeeS format for USFDA, EU, and other markets.

- Handle amendments, annual updates, and deficiency responses in accordance with regulatory timelines.

- Regulatory Submissions & Compliance: Coordinate with R&D, Quality, and Manufacturing teams to compile technical data, ensuring compliance with Good Documentation Practices (GDP) & Regulatory formats.

- Regulatory Communication & Strategy: Liaise with regulatory authorities (USFDA, EU-GMP, TGA, etc. ) for approvals and regulatory updates.

- Provide guidance to internal teams on compliance strategies.

- Audits & Documentation: Support regulatory inspections and audits, ensuring all regulatory documents are up-to-date and readily available.

- Train internal teams on regulatory aspects and submission processes.

Qualifications & Experience:

- Education: M. Pharm / B. Pharm / M. Sc. in Pharmaceutical Sciences, Regulatory Affairs, or Chemistry.

- Experience: 10+ years in Regulatory Affairs, with a specific focus on DMF & CEP filing.

Key Skills & Competencies:

- Strong knowledge of regulatory guidelines and submission required.

- Excellent analytical, documentation, communication and writing skills.

- Ability to manage multiple projects while meeting regulatory timelines.

- Strong stakeholder management skills.