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Manager - Regulatory Affairs
Global Calcium
posted 13hr ago
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Flexible timing
Key skills for the job
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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What people at Global Calcium are saying
Regulatory Affairs Manager salary at Global Calcium
reported by
1
employee
with 11
years exp.
₹9.4
L/yr - ₹12.1
L/yr
37%
less
than the average Regulatory Affairs Manager Salary in India
View more details
What Global Calcium employees are saying about work life
based on 282 employees
Flexible timing
Monday to Saturday
No travel
Day Shift
Global Calcium Benefits
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