Senior Regulatory Affairs Program Lead

Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Regulatory Affairs Program Lead , to be located in Cincinnati, Ohio; Raynham, MA; Raritan, NJ or Santa Clara, CA.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

The Senior Regulatory Affairs Program Lead executes the Regulatory Affairs platform strategy. We support regional and country product registrations, monitor and assess impacts of product specific regulations for new products as well as lifecycle product registrations.

In this role, you will:

• Provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified global product launches and related regulatory activities.

• Complete the preparation and submission of regulatory information required to obtain global market access, identifying risk and issues, effectively communicating timelines for project completion, and addressing issues that may impact registration status.

• Execute on plans that directly impact the operational results.

• Work closely with Research and Development, Medical Affairs, Quality Engineering, Product Management, Labeling, as well as global Regulatory Affairs affiliates.

• Support clinical strategy and work with clinical teams to support regulatory submissions.