Regulatory Affairs Manager
Proclinical is currently is seeking a Manager of Regulatory Affairs for a specialty pharmaceutical company at its East Hanover, NJ corporate office. Successful individual for this role will have 5+ years of experience working in US FDA regulated pharmaceutical development and manufacturing. Candidates with experience working with CMC documentation is preferred.
- Compose and coordinate all regulatory submissions of the company including original ANDAs, supplements, CBE-30s, annual reports, SPLs, PADERs and 505(b)(2) filings.
- Ensure compliance with all post-approval regulatory filing deadlines and oversee life cycle management of regulatory submissions.
- Maintain drug product labeling components for all commercial products.
- Drug listing for all products.
- Review documents received from CMOs for completeness.
- Review change controls for completeness and accuracy, assessing impact to regulatory filings.
- Keep abreast of regulatory knowledge and initiatives including ICH, USP and other regulatory intelligence sources.
Skills and Requirements:
- BA/BS with 5+ years work experience in US FDA regulated pharmaceutical development and manufacturing.
- Experience with US FDA ANDA submissions in eCTD format required.
- Strong background in chemistry, manufacturing and controls documentation preferred.
- Excellent organizational and time management skills, as well as communication and interpersonal skills across all levels of the Company.
- Self-starter who can be effective with minimal supervision.
- Previous experience working in a small-to-midsize company environment.
- Excellent writing skills consistent with the ability to prepare concise, timely and accurate reports.
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 Anula Aboobacker at (+1) 646-367-2909 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.
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