Sr. Officer Regulatory Affairs
4 days ago
Roles & Responsibilities
Regulatory Submissions & Filings
- Prepare, review, and submit DMFs, CEPs, and regulatory dossiers for API registration in global markets (USFDA, EMA, WHO, etc.).
- Ensure submissions are complete, accurate, and in CTD/eCTD format.
- Coordinate with internal teams to gather technical and manufacturing data for filings.
- Track submissions, approvals, and queries from regulatory authorities and ensure timely responses.
Dossier Preparation & Maintenance
- Prepare and maintain dossiers in compliance with current regulatory standards and GMP requirements.
- Update existing dossiers to reflect process or analytical changes.
- Review and compile CMC (Chemistry, Manufacturing & Controls) documentation.
- Ensure accurate electronic storage and document retrieval systems.
Regulatory Compliance & Standards
- Monitor global regulatory changes and implement updates as required.
- Support development of regulatory strategies for product approvals.
- Participate in regulatory inspections, audits, and internal compliance reviews.
- Ensure continuous adherence to international pharmaceutical regulations.
Documentation & Control
- Ensure compliance with Good Documentation Practices (GDP).
- Maintain regulatory databases, archives, and document control procedures.
- Prepare and review regulatory reports, summaries, and submissions.
- Safeguard the integrity and completeness of all regulatory documentation.
Collaboration & Communication
- Liaise with external regulatory consultants, agencies, and internal teams (R&D, QA, QC, Production).
- Provide regulatory guidance for product and process changes.
- Present updates and regulatory insights to management.
- Participate in meetings, audits, and conferences related to regulatory affairs.
Risk Assessment & Mitigation
- Identify potential regulatory risks and conduct impact assessments.
- Develop and implement mitigation strategies to ensure compliance.
- Monitor regulatory trends to anticipate and address emerging challenges.
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