Associate Director - Global Regulatory Affairs

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Job Title: Associate Director - Global Regulatory Affairs Location: Cambridge, MA - Hybrid
Job Responsibilities: Lead and manage regulatory activities for multiple projects, ensuring compliance with global standards. Develop and implement regulatory strategies focusing on non-clinical and clinical drug development. Serve as the primary regulatory contact for the FDA, managing submissions and approvals. Collaborate with global teams to create and execute comprehensive regulatory strategies. Oversee and guide direct reports, ensuring timely and accurate regulatory submissions. Lead agency meetings and provide regulatory expertise to development teams.
Skills Required: Minimum of 8 years in the pharmaceutical industry, with at least 6 years in regulatory roles. Strong understanding of drug development processes and regulatory requirements. Experience with major regulatory filings and strategy development. Excellent communication and negotiation skills. Ability to lead and manage teams effectively. Proficient in developing creative solutions and risk mitigation strategies.
Education: Bachelor's degree required; advanced degree preferred.
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Location:
Cambridge
Job Type:
FullTime

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