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CMC Biologics Lead
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Proclinical is seeking a CMC Biologics Lead for a Regulatory Affairs service provider, to be based in London on a contract basis.
Job Responsibilties:
- To prepare regulatory strategies for various types of LCM submissions and post approval change submissions (QC, DS/DP site transfer changes, facility/ equipment changes, cell bank transfer/ new cell bank generation changes).
- Preparation and finalization of regulatory submission planner for large programs that involves multi products, multi countries submissions; and tracking of the submissions status on ongoing basis.
- To prepare submission TOC & submission check list for various types of regulatory submissions (Variations, initial submissions, response to health authority queries).
- Evaluation of CPP requirements for various submission types and preparation of global submission strategies / submission roadmaps based on CPP requirements.
- To prepare variation packages / regulatory submission packages in various formats (CTD, ACTD, country specific formats etc.).
- To perform technical gap assessment against regulatory requirements and the source data received from different teams (R&D, QC, Manufacturing etc..).
- Peer review of the regulatory submissions/ dossiers/ deliverables prepared by CMC team and to ensure necessary corrections/ updates for identified gaps (internal and client partner review points).
- Coordinating with client CMC teams, International Regulatory teams and Regulatory operations teams for proposing/ finalizing the regulatory strategies for various programs under the scope.
- Periodic update/ meetings (weekly, by weekly, monthly) with client partner CMC teams, International Regulatory teams and Regulatory operations teams to discuss the completed/ ongoing status of each regulatory program under the project scope and to resolve identified issues related to project.
Skills and Requirements:
- Bachelor's degree in Chemistry, Chemical Engineering, Pharmacy, or closely related field is required
- Advanced degree in Chemistry, Chemical Engineering, Pharmacy, or closely related field is desirable
- Minimum 15 experience in the Biopharmaceutical Industry, or relevant Regulatory environment (in Biologics).
- Demonstrated experience and Knowledge on Biological products/Plasma products/ recombinant products regulatory submissions and life cycle management support in the global regulatory environment (EU, Japan, Australia, CIS, APAC, MENA, LATAM).
- Good understanding on Biological products/ Plasma products/ recombinant products regulatory requirements for initial MA submissions and post approval changes submissions (variations/ supplements) in the different geographic regions (EU, Japan, Australia, CIS, APAC, MENA, LATAM).
- Hands on experience in preparation and submission of Biological products marketing authorization applications (BLAs, MAAs, registration dossiers etc..) and post approval changes submissions (Variations, supplements).
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Jay Foster on +44 203 752 0309 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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