Executive Director, Global Regulatory Affairs

November 23

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501 - 1000

Description

• Lead the global regulatory strategy for companion diagnostics. • Coordinate all regulatory submissions for companion diagnostics, including IDE and PMA applications. • Work closely with cross-functional teams and external partners. • Ensure all companion diagnostic products comply with applicable global regulatory requirements. • Develop and maintain productive relationships with regulatory agencies.

Requirements

• Bachelor’s, Master’s, or PhD in Life Sciences, Regulatory Affairs, or a related field. • Regulatory Affairs Certification (RAC) or similar credential is a plus. • 12+ years of regulatory experience in the life sciences industry, with at least 5 years focused on companion diagnostics or related diagnostic products. • Proven track record of managing regulatory submissions and approvals for diagnostic devices, ideally within the pharmaceutical industry or with drug-diagnostic co-development programs. • Deep understanding of regulatory guidelines and requirements for in vitro diagnostics (IVDs), medical devices, and companion diagnostics, particularly in the U.S. (FDA) and EU (EMA). • Experience with global regulatory health authorities, including successful submissions and interactions with agencies such as FDA, EMA, and PMDA. • Strong project management and organizational skills with the ability to manage multiple complex projects simultaneously. • Demonstrated leadership and team management skills with experience leading regulatory teams.

Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness