Similar Jobs
See allDirector, Global Regulatory Affairs
EVERSANA
US
Negotiation
Project Management
Communication
Senior Manager, Regulatory Affairs
RayzeBio
US
Leadership
Communication
MS Office
Executive Director, Regulatory CMC
BridgeBio
US
Regulatory Affairs
CMC
Regulatory Affairs-CMC Strategist (Small Molecules)
Antares Therapeutics
US
Regulatory Affairs
CMC
Regulatory Affairs Consultant
Parexel
Europe
CMC
Regulatory Affairs
Quality Assurance
Responsibilities:
- Serve as the primary point of contact with FDA and other health authorities.
- Lead regulatory agency meetings and coordinate the preparation of supporting meeting materials.
- Partner with and support Clinical, Nonclinical, CMC, and Safety & Pharmacovigilance activities.
Experience:
- A minimum of 10 years of experience in regulatory affairs, including serving as Global Regulatory Lead.
- Hands-on experience with INDs and/or CTAs and writing regulatory documents.
- Experience leading regulatory agency interactions and meetings.
Skills:
- Strong strategic skills including demonstrated ability to make complex decisions.
- Strong written and verbal communication skills with a collaborative, team-oriented approach.
- Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude.
Braveheart Bio
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, they represent an outstanding opportunity for ambitious, mission-driven professionals.