Manager - Regulatory Affairs
Manager - Regulatory Affairs
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Salary Not Disclosed
1 Vacancy
Job Description
- 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 EUGMP 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 uptodate and readily available. Train internal teams on regulatory aspects and submission processes.
- Education: / / . in Pharmaceutical Sciences Regulatory Affairs or Chemistry.
- Experience: 10 years in Regulatory Affairs with a specific focus on DMF & CEP filing.
- 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.
data analysis,regulatory submissions,stakeholder management,dmf,team leadership,problem solving,project management,compliance,documentation skills,eu regulatory compliance,regulatory affairs,communication skills,documentation,technical writing,good documentation practices (gdp),usfda compliance,regulatory strategies,analytical skills,drug master file (dmf) preparation,writing skills,cep filings
Employment Type
Full Time
