
Pharmaceutical Compliance Manager
4 days ago
We are seeking a highly experienced Regulatory Affairs Specialist to lead our pharmaceutical manufacturing plant's compliance with DRAP regulations.
Key Responsibilities:
- Prepare, review, and submit CTD dossiers (FORM-5, FORM-5F) for the plant's Drug Manufacturing License (DML).
- Expedite approvals by directly engaging DRAP authorities to resolve queries.
- Monitor evolving DRAP guidelines and implement compliance updates.
- Maintain audit-ready regulatory records (submissions, licenses, correspondence).
- Collaborate with QA/QC teams to enforce GMP/DRAP standards.
Qualifications:
- Education: Bachelor's/Master's in Pharmacy.
- Experience: 2–5 years in DRAP regulatory affairs, including:
- Successful DML applications for pharmaceutical plants.
- CTD dossier (FORM-5/5F) preparation and submission.
- Technical Skills:
- Expertise in DRAP processes, GMP, and quality systems.
- Proficiency in MS Office & regulatory databases.
Benefits:
- Lead compliance for a cutting-edge pharma plant launch.
- Shape regulatory strategy from the ground up.
- Competitive salary + performance-based incentives.
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