Senior Regulatory Strategy Manager

HIRING: Senior Regulatory Strategy Manager - Healthcare Services & Technology - New York
Hays Life Sciences is currently partnered with a growing oncology-focused healthcare services and technology company to assist in their search for a Manager/Senior Manager, Regulatory Strategy. This company has active partnerships with many of the top life sciences companies and academic medical centers as well as the FDA where they are able to use their innovative real-world evidence platform in the oncology space. They are looking to build out their Regulatory Affairs department and as a result, are working to add this Manager/Senior Manager, Regulatory Strategy to their department. This is a key role within an expanding function/department for this organization.

In this capacity, you will be responsible for supporting relationships with their life science partners’ regulatory teams. You will leverage your regulatory expertise to assist the company and their partners in navigating the regulatory landscape for submissions using real-world evidence. In addition, you will define and implement the company’s regulatory strategy, operations and best practices. You will curate solutions to regulatory issues using real-world evidence. You will serve as the subject matter expert to coordinate responses to information requests from regulators. You will also stay up-to-date with regulations relevant to oncology products.

At minimum, you must possess 6 years of Regulatory Affairs experience in FDA submissions (NDA’s/BLA’s) in a highly regulated environment (pharma/biotech/CRO), direct experience with post-market applications (labeling and promotional review) and strong written and verbal communication skills.

Apply now for consideration.


Job type:
Full Time
New York
Competitive / Based on Experience
Apply Now

Talk to a consultant

Talk to Phu Huynh, the specialist consultant managing this position, located in New York City

16th Floor, 200 West 41st St

Telephone: 212 548 4525

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