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
• 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
• 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