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Engaged Employer

Global Calcium

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3.8

based on 286 Reviews

Video summary

31 Global Calcium Jobs

Manager - Regulatory Affairs

Global Calcium Pvt. Ltd

3.8

based on 286 Reviews

10-15 years

Hosur

1 vacancy

Manager - Regulatory Affairs

Global Calcium

posted 4d ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacy Software Configuration Management Auditing Regulatory Affairs Analytical Chemistry Compliance

+ 3 more

Job Description

Job Summary:

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.

Employment Type: Full Time, Permanent

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