Regulatory Project Lead
ProClinical, in support of our client, are seeking an individual to fill the role of Regulatory Project Lead, based in Maryland.
- Lead or participate in preparation of filing for assigned IND, CTA and NDA submissions to FDA or other health authorities.
- May manage interactions with FDA, EMA and other regulatory authorities.
- Provide regulatory support and guidance to cross-functional teams and ensure all applicable global regulatory requirements are considered and appropriately incorporated into clinical and commercial products.
- Function as RA representative in development project team.
- Work with other functions of the company and development teams to establish and implement global regulatory strategy and plan for assigned projects.
- Ensure that all due dates for regulatory milestones are met with quality deliverables.
Skills And Qualifications
- BS in Life Sciences or Chemistry required (advanced degree strongly preferred), 7+ years of relevant industry experience and 5+ years of regulatory affairs project lead experience.
- Experience in filing IND and NDA for small molecule innovative drug required.
- Experience in establishing global regulatory strategy and plan for early and late development projects.
- Experience with interacting with FDA is essential, and global experience strongly preferred.
- Experience with oncology drug development strongly preferred.
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.
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