Project Lead, Regulatory Affairs

Proclinical is currently recruiting for a Project Lead of Regulatory Affairs for a global biotechnology company located in Rockville, MD. Successful candidate will lead and execute regulatory strategy and filings.

Job Responsibilities:

• Lead or participate in preparation of filing for assigned IND, CTA and NDA submissions to FDA or other health authorities.
• Manage the interactions with FDA, EMA and other 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 closely with other functions of the company, including quality assurance, clinical development, pharmacovigilance, CMC, clinical operations, and project management.
• Responsible for working with development teams to establish and implement global regulatory strategy and plan for assigned projects.
• Ensure that all internal and external due dates for regulatory milestones are met with quality deliverables.
• Might lead FDA or other health authority meetings or meeting rehearsals.

Skills and Requirements:

• BS in Life Sciences or Chemistry required; advanced degree highly preferred.
• 7+ years of pharmaceutical or biotech industry experience.
• 5+ years of hands-on regulatory affairs project lead experience.
• Experience in filing IND and NDA for small molecule innovative drug is essential.
• Experience in establishing global regulatory strategy and plan for early and late development projects.
• Experience with interacting with FDA is essential, and global experience is highly preferred.
• Experience with oncology drug development is highly desirable.

To Apply:

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 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.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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