Regulatory Affairs CMC Senior Manager
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.
- Working with internal stakeholders, 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 the timely completion of appropriate regulatory filings such as CTA, IMPD, IND and associated amendments.
- 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 to ensure the quality and safety of clinical product.
Skills and Qualifications
- BA in scientific/engineering discipline (advanced degree preferred). 5+ years of pharmaceutical industry experience and working knowledge of drug development process. Additionally, 3+ years of regulatory CMC experience.
- Must have experience in pharmaceutical development.
- Experience with post-marketing regulatory activities and requirements a plus.
- Ability to resolve complex and ambiguous situations, with ability to understand the scientific principles as it relates to regulatory requirements and strategy.
- Strong proficiency in Microsoft Office suite.
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 Tudor Carr at (+1) 617-545-5919 or upload your resume 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.
€0.00 - €120000.00 per annum
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