Backed by 5AM Ventures.
About the role
Reporting to the Senior Vice President of Regulatory, t he Senior Director of Regulatory Affairs will support regulatory strategy and lead regulatory execution for the company’s development programs, ensuring compliance with global health authority requirements (FDA, EMA, and other regulatory agencies).
What they're looking for
- Bachelor’s, Master’s, PharmD, or PhD, preferably in life sciences
- Minimum of 8 years of Regulatory experience
- D irect experience leading /supporting FDA interactions
- Ability to oversee regulatory activities and manage processes from research/discovery, CMC, and clinical and manage process from clinical development through to commercialization planning
- US registration experience ideal
- Experience with small molecules and pain ( or similar area ) is preferred
More about this role
This position can be located in
Thousand Oaks, CA , San Francisco Bay Area , CA or Washington, D.C. area
Reporting to the Senior Vice President of Regulatory, t he Senior Director of Regulatory Affairs will support regulatory strategy and lead regulatory execution for the company’s development programs, ensuring compliance with global health authority requirements (FDA, EMA, and other regulatory agencies). This role will be responsible for developing and implementing regulatory activities to support the clinical development plans including leading submissions, managing regulatory vendors, support of regulatory interactions, and providing
regulatory guidance to cross-functional teams.
Regulatory Strategy & Leadership
- Lead execution and implement ation
of regulatory strategies to support product development .
- S upport regulatory interactions with global health authorities, including FDA, EMA, MHRA, and others.
- Provide regulatory input into clinical development plans, study designs, labeling strategies etc.
- Anticipate and mitigate regulatory risks; develop contingency plans as needed.
Submissions & Compliance
- Oversee the preparation, review, and submission of high-quality...
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