Senior Regulatory Affairs Program Lead
Company: Disability Solutions
Location: Cincinnati
Posted on: May 3, 2024
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Job Description:
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 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.
Keywords: Disability Solutions, Covington , Senior Regulatory Affairs Program Lead, Other , Cincinnati, Kentucky
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