Global Regulatory Affairs Senior Manager – Biotech

Braveheart Bio; San Francisco (CA); Hybrid; USD 170,000 - 195,000; Full time

Benefits offered by this job

Competitive total rewards

Equity

Comprehensive benefits

Job summary

Braveheart Bio is seeking a Senior Manager, Regulatory Affairs to drive global regulatory submissions and strategy. You will lead U.S. IND/NDA and ex-U.S. CTA/MAA activities, manage health authority interactions, and collaborate with cross-functional teams to ensure timely approvals.

The role requires strong knowledge of U.S. FDA regulations and EU CTR/CTIS, plus hands-on experience with INDs and CTAs. A fast-paced biotech environment awaits a strategic, hands-on leader.

Qualifications

• 7+ years regulatory affairs experience in biotech/pharma.
• Hands-on with U.S. IND submissions and EU CTA submissions.
• Experience with health authority interactions and response management.
• Knowledge of FDA regulations and EU regulatory frameworks.
• Experience with lifecycle management of INDs/CTAs.
• Strong writing and project management skills.

Responsibilities

• Lead US IND/NDA submissions and lifecycle management.
• Lead ex-U.S. CTAs/MAA submissions and regulatory interactions.
• Develop and execute global regulatory strategy and timelines.
• Oversee regulatory vendors and ensure on-time delivery.
• Collaborate across Clinical, CMC, and Quality teams.

Skills

Regulatory affairs

IND submissions

EU CTA submissions

Health authority liaison

Project management

Regulatory strategy

Writing regulatory docs

Education

Advanced degree (MS/PhD/PharmD)

Tools

Veeva RIM

Job description

Braveheart Bio is seeking a Senior Manager, Regulatory Affairs to drive global regulatory submissions and strategy. You will lead U.S. IND/NDA and ex-U.S. CTA/MAA activities, manage health authority interactions, and collaborate with cross-functional teams to ensure timely approvals.

The role requires strong knowledge of U.S. FDA regulations and EU CTR/CTIS, plus hands-on experience with INDs and CTAs. A fast-paced biotech environment awaits a strategic, hands-on leader.