Associate Director, Regulatory Affairs
$197k/y-$240k/y
BioSpacea day ago
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OnsiteFull-timeSenior
Summary
Maze Therapeutics is seeking an Associate Director, Regulatory Affairs to join their team in South San Francisco, CA. The role involves providing regulatory expertise and executional leadership to advance clinical-stage programs.
About the Role
As an Associate Director, Regulatory Affairs, you will represent Regulatory Affairs for assigned programs, manage global regulatory activities, prepare regulatory submissions, and facilitate interactions with Health Authorities. You will also contribute to regulatory strategies, conduct regulatory research, and ensure compliance with regulatory expectations while collaborating with cross-functional teams.
About You
Required:
- Bachelor's degree required; advanced degree in life sciences preferred.
- 7+ years of relevant experience in regulatory affairs in the biopharmaceutical industry.
- Strong understanding of ICH guidelines and US/EU regulatory requirements.
- Hands-on experience preparing and managing IND/CTAs and related submissions.
Preferred:
- NDA/MAA experience.
- Ability to manage multiple projects in a fast-paced environment.
- Strong organizational and communication skills.
Benefits
- Competitive medical, dental, and vision insurance.
- Mental health offerings.
- Equity incentive plan.
- 401(k) program with employer match.
- Generous holiday and PTO policy.
- Annual performance bonus.
BioSpace
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South San Francisco, CA