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Associate Director Regulatory Affairs

Company: Regulatory Connect
Location: San Diego
Posted on: September 17, 2020

Job Description:

Associate Director of Global Regulatory Affairs – Opportunity to be remote after handover

Regulatory Connect has partnered with a leading global regenerative medicine company with cell-based products in various stages of research, development and clinical trial testing. The Company’s vision is to create and lead the field of regenerative medicine and the Company is currently one of the leading companies in the CNS therapeutic area.

This role can be offered either on a Contract basis or a permanent, the scope of the role is to

Your Role:

• Author and coordinate the preparation & review of regulatory documents or submissions to facilitate marketing authorization.

• Identify and ensure compliance with regulatory requirements for U.S. submissions.

• Interpret existing and/or new regulatory requirements as they relate to company products and procedures.

• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.

• Interact with the FDA and other regulatory bodies as needed.

• Ensure regulatory inspection readiness activities and internal audits of company systems and processes.

• Participate on product development teams to ensure US and other international regulatory requirements are incorporated as part of the development process.

This role offers an exciting opportunity for a talented professional to contribute to the breadth and depth of their regulatory expertise as well as developing significant career experience in the emerging field of regenerative medicine.

US Office – We Work 980 6th Ave Bromley, New York NY 10018

Keywords: Regulatory Connect, San Diego , Associate Director Regulatory Affairs, Other , San Diego, California

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