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Scientific. Clinical. Software Engineering

Senior Director, Global Regulatory Affairs (GRA)

Edison-New Brunswick Metro Area, NJ

Job Type: Scientific Job Number: JN -042020-26684 Region: Edison-New Brunswick Metro Area

Job Description

Duties:

The Senior Director of North America Regulatory Strategy (NA GRA) will be primarily responsible for the development of US regulatory strategy to advance company s portfolio of development pipeline candidates and life cycle management of marketed products. Reporting to the Associate Vice President of North America Regulatory Affairs, this individual will work within the Global Regulatory Team to provide strategic input and ensure operational execution of US submission activities for the company s portfolio. The individual will be responsible to interface directly with the US FDA as the primary contact for the company for assigned programs. The position may be based at either Bridgewater, NJ; Waltham, MA or Cambridge, MA.


Skills:

Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.

Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving US regulatory policy and guidance

Direct interaction/negotiation with regulatory authorities (e.g. FDA)

Ability to motivate and lead others

Team player, ability to work well within cross-functional teams and in a multicultural/multinational environment

Excellent oral communication and writing skills

Change management/ change enabler : embraces the challenges of a fast changing environment

Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities

Excellent operational skills

Unquestionable ethics, professional integrity, and personal values consistent with the company values


Education:

BS degree in a relevant scientific discipline. Advanced degree is preferred (MS/PhD/PharmD)

10-15 years industry experience, with at least 6-9years working in regulatory affairs (US or globally).

Delivery of a number of major applications (NDA/BLA/IND, etc )

Experience with late stage development/marketed products

Prior experience in the rare disease, rare blood disorders, or immunology therapeutic areas, a plus

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