
R & D/ Regulatory Officer (Female)
3 hours ago
Qualification: Pharm-D
Experience: 1–2 Years
Job Description:
We are looking for a qualified and detail-oriented Female R&D Officer (Dossier & Regulatory Affairs) to support dossier preparation and regulatory documentation activities in compliance with DRAP, CTD, and ACTD guidelines.
Key Responsibilities:
- Prepare, compile, and review CTD / ACTD dossiers for registration of pharmaceutical products (local & export markets).
- Ensure dossier content complies with DRAP, ICH, WHO, and other international regulatory requirements.
- Collect and verify technical documents from Production, QA, QC, and Formulation departments.
- Prepare Product Registration Files, Renewal Applications, and Variation Submissions.
- Maintain and update regulatory databases, registration status trackers, and documentation archives.
- Coordinate with regulatory authorities and respond to queries or deficiency letters.
- Support the R&D and Regulatory team in product development documentation and regulatory strategy.
- Stay updated on latest DRAP guidelines, CTD/ACTD structure changes, and industry best practices.
Skills & Competencies:
- Strong knowledge of CTD & ACTD dossier formats.
- Understanding of pharmaceutical formulation and documentation.
- Proficiency in MS Office (Word, Excel, PowerPoint).
- Excellent communication, organization, and documentation skills.
- Attention to detail and ability to work independently.
Location: Multan Chung, Lahore
Job Type: Full-time
Work Location: In person
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