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Executive - Regulatory Affairs
Arco Lab
posted 17d ago
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Flexible timing
Key skills for the job
Job Description
- Responsible for compilation and assist team for projects and regulatory submissions by collating documents per regulatory requirements for EU/UK market for CMC and labeling aspects.
- Review and approval of documents required for compilation of regulatory submissions and deficiencies responses.
- Ensure relevant SOPs are understood and practiced on routine basis.
- Preparation, Review and Compilation of regulatory documents for post approval variations (Type 1A, Type 1B, Type II, renewals etc.) being filed to EU/UK market.
- Coordinate with the cross functional departments for primary data documents, required for submission. Collate and review primary data received from different departments towards regulatory dossier compilation.
- Uploading and formalization of documents in eCTD format using eCTD dossier management software.
- To assist regulatory supervisor/ head in formulizing various regulatory documents as required for formalizing regulatory strategy for various submissions.
- Any other responsibilities assigned by Supervisor/Head.
- Collaborate with regulatory affairs team to help prepare MA Variations filings, regulatory due diligence supporting in-licensed products amongst others while ensuring they are in conformance with guidelines and regulatory standards are met.
- Critically review documentation intended for submission to the MHRA and EU for internal consistency.
- Review of Product Master File as and when any changes and provide the recent version to releasing QP upon their request.
Employment Type: Full Time, Permanent
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