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Job Description & How to Apply Below
UK:
- Drug Dossier Authoring, Reviewing & Submission of dossiers
Product life cycle management (LCM) activities
Assessment of post approval changes
eCTD publishing
Thorough knowledge of CMC and Module 1 requirements
Labelling submission
Preparation & Submission:
- Draft, critically review, and submit high‑quality regulatory dossiers (e.g., MAAs, variations, renewals) in eCTD format, ensuring alignment with EU (EMA/NCAs) and UK (MHRA) requirements, region‑specific templates, and submission portals (e.g., IRIS , MHRA regulatory connect, submission gateway etc. ).
Lead end‑to‑end maintenance of approved products, including renewals, CMC updates, safety changes and administrative updates, coordinating across functions to keep EU/UK marketing authorizations compliant and current.
Understanding of the ICH, EMA, CmDH, UK and other country specific guidance’s
Compile, validate, and publish submissions in eCTD (Modules 1–5), including lifecycle operations (sequences, baselines), technical validation (e.g., EU/UK eCTD validation criteria ) and upload via the appropriate EU/UK portals.
Demonstrate strong expertise in CMC (Module
3) for DS/DP and Module 1 regional requirements for UK admin info, forms, SmPC/PL/label mock‑ups, RMPs, package leaflet readability, environmental/UK‑specific declarations).
Review site documents required for submission
Prepare, update, and submit SmPC, PIL/PL, and artworks as per the agency’s requirement, track approvals, and oversee artwork implementation at manufacturing site.
Preparation of scientific advice package
Timely submission of the query response to the agency and other business partner
Coordination:
- Interface with R&D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner
Co-ordination with API vendors to resolve technical quires w.r.t. regulatory requirements
arrange and review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R&D/ADL against DMF/Dossier requirements
Reporting & Maintenance:
- Maintain regulatory tracker, files/database
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