Senior RA Manager CMC
ProClinical, in support of our client, are seeking an individual to fill the role of Senior Manager of Regulatory Affairs, CMC, based in Cambridge, MA. The successful candidate will be responsible for developing global regulatory strategies to advance the company's portfolio. This position will lead and contribute to activities in support of high-quality CMC sections of regulatory documentation.
- Work with internal stakeholders to develop regulatory CMC strategies, identify potential regulatory risks, and develop appropriate contingency plans for projects in various phases of development.
- Manage and lead assigned projects, including timelines and submission planning. Plan and prepare CMC documentation for Clinical Trial Applications, IND submissions and amendments, marketing applications, supplements, variations and other communications with regulatory authorities.
- Ensure completion of appropriate regulatory filings.
- Evaluate CMC change controls and provide regulatory input pertaining to all facets of manufacturing changes.
- Exercise good judgement in elevating and communicating actual or potential issues.
- Provide feedback and guidance in accordance with phase appropriate regulatory expectations.
- Set and drive aggressive product timelines.
Skills And Qualifications
- BA in scientific/engineering discipline (advanced degree preferred) and 5+ years of experience and knowledge of drug development process. Experience in pharmaceutical development required.
- 3+ years of regulatory CMC experience with product development and CMC life cycle management.
- Experience with post-marketing regulatory activities and requirements a plus.
- Proficiency in Microsoft Office suite.
- At home in a results-driven, highly accountable environment where you can make a clear impact.
In case you have difficulty in applying or if you have any questions, please call Nicholas Walker at (+1) 646-367-2908 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
£0.00 - £140000.00 per annum
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