Bohan and Bradstreet

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Regulatory Affairs Leader

Location/City: CT - North Haven
Salary Range: 75000.00 - 90000.00 per year (USD Permanent)

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Mark R. Proft

Mark R. Proft

Position Description

Job ID: 12668
Industry: Manufacturing

VISION: Innovative biomedical research and clinical care start-up, pursuing drug approvals in the EU and US and seeking a full-time Regulatory Affairs Leader to direct and manage the application process.  Join a collaborative, global team operating in an open culture, and focused on developing solutions to previously unmet patient needs. With operations in the greater-New Haven, CT area, this is an ideal role for detail-oriented and hands-on professional who can meet deadlines, likes international business, has worked with FDA regulations and compliance, wants to make a difference, and looks for upside career potential.


OPPORTUNITY: Report to the VP of R&D. Prepare and submit domestic and international regulatory applications for clinical trials; while providing oversight to effectively plan and manage regulatory variations. Interact with production, international regulatory, and quality to obtain required documents for the file creation and maintenance. Understand regulatory requirements in US and EU countries where operating.


Develop and maintain relationships with international and local authorities throughout the application process which may also include special status applications and pediatric investigation plans. Build the regulatory team as the organization grows.


REQUIREMENTS:  BS/BA degree preferably in Life Sciences, Pharma, or Law.  Advanced degrees are advantageous. We are looking for 3+ years of experience with regulatory compliance of pharmaceutical or medical products. Must have international regulatory experience.  Must have strong written, oral, and computer skills.


REWARD: $75,000 to $90,000 depending on experience, plus benefits, and the opportunity to work with a highly passionate global team of professionals.  


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