CMC Regulatory Affairs Manager
Responsibilities :
- Responsible for preparation of the Quality sections of INDs / IMPDs, new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for a range of biologics products.
- Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans. Ensure dossiers meet ICH and local regulatory requirements.
- Act as the regional CMC Regulatory lead for assigned products and territories within a global matrix team, contributing to global CMC regulatory strategies for the international markets.
- Liaise with colleagues in Regulatory Affairs therapeutics teams, , Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines.
- Co-ordinate regulatory assessments for post-approval CMC changes, develop filing strategy and plans for assigned markets and execute filings according to agreed priorities.
- Maintain a current awareness of CMC registration requirements in each of the international regions and communicate key regulatory intelligence to the organization on a timely basis.
Requirements :
- BA / BS, MS or Ph. D or equivalent education.
- Significant experience in Regulatory Affairs CMC and / or relevant pharmaceutical industry experience.
- Experience in the preparation of CMC components of MAA or post-approval variation submissions for small molecule and / or biologics products.
- Biologics experience or drug-device combination product experience would be an advantage.
- A proven ability to co-ordinate the preparation of a variety of CMC regulatory documents in collaboration with other functions.
- Proven strategic thinking skills, with a proven track record for developing global CMC regulatory strategies in multiple markets simultaneously.
- An in-depth knowledge of ICH and regional CMC regulatory requirements, and an understanding of current global and regional trends in CMC Regulatory Affairs.
- Experience representing CMC regulatory affairs on regulatory and cross functional teams.
- Excellent written and verbal communication skills.
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