Senior Director, Regulatory Affairs

Position:
Senior Director, Regulatory Affairs

Company:
Orca Bio

Compensation:
$250,000 - $300,000 a year

Location:
United States, Menlo Park, CA

Employment type:
Regular, Full-Time Employee

Work Arrangement:
On-site

Short Summary:
The Senior Director, Regulatory Affairs is Orca Bio's functional Head of Regulatory Affairs, leading the Regulatory Affairs function and serving as the company's primary regulatory subject-matter expert and advisor. The role focuses on post-approval regulatory operations and lifecycle management while maintaining regulatory readiness for future development programs.

Responsibilities:
- Lead Orca Bio's Regulatory Affairs function and serve as the company's senior regulatory leader.
- Advise executive leadership on strategy, health-authority engagement, lifecycle planning, risks, and emerging requirements.
- Develop and recommend regulatory strategy in partnership with executive leadership.
- Lead near-term post-approval regulatory execution, including commercial-stage supplements and variations.
- Provide ongoing compliance support for the commercialized product.
- Lead ongoing interactions with the FDA, EMA, and other health authorities.
- Partner closely with Clinical, CMC, Quality, Pharmacovigilance, and Commercial teams.
- Maintain and continuously improve regulatory affairs systems, trackers, and records.
- Lead and develop the Regulatory Affairs team.

Requirement:
- Bachelor’s degree in life sciences or a related discipline required.
- 10+ years of regulatory affairs experience in the biotechnology or pharmaceutical industry.
- Track record of participating in approval of a commercial-stage product strongly preferred.
- Demonstrated success managing post-approval regulatory activities.
- Proven people leader with a track record of building, coaching, and developing high-performing teams.
- Excellent written and verbal communication skills.

Benefits:
- Eligible for pre-IPO equity and annual bonus.
- Competitive medical, dental, and vision benefits.
- PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits.
- Subsidized daily lunches and snacks at on-site locations.