U.S. Regulatory Lead job in Cambridge, USA

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First Name*

Last Name*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Labelling & Artwork, Publishing & Submissions, Operations

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a U.S. Regulatory Lead with a biotechnology company located in Cambridge, MA.

Job Responsibilities:

Core member of the RPT collaboratively working with the team to represent the US Business and weave US strategies into global strategies as they are developed.
US participant on Product Cross Functional Team as appropriate.
Key contact for FDA on product(s) and with direct FDA interaction. Ensures communications from FDA are properly communicated to the business after assessing the feedback and outlining next steps.
Key contact for internal research, development and business partners on product(s).
Drive US product labeling, working with the GRL to ensure core label changes are appropriately conveyed in US product labeling. Partners with US Commercial and Ad Promo Team.
Responsible for IND, NDA, and BLA submissions to FDA in partners with Regulatory Operations.
Responsible for product labeling, working with the GRL to ensure core label changes are appropriately conveyed in US product labeling.
Regulatory representative on due diligence assessments of new business opportunities as required.
Provide mentorship to junior regulatory staff.

Skills and Requirements:

8+ years pharmaceutical industry experience in R&D, Regulatory or related functions, with at least 5 years working in regulatory affairs.
Delivery of at least one major application (NDA or BLA) or extensive experience with neurology late stage development/marketed products.
Great leadership skills with high emotional intelligence.
Must be a great team player with strong verbal and written communication skills.

If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914.

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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