Reg Affairs Assoc. Director
About the role
Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.
What You'll Do
The Associate Director/Director, Regulatory Advertising & Promotion is responsible for providing strategic regulatory leadership for promotional materials and external communications across assigned programs or brands. This role ensures that all promotional activities are compliant with FDA regulations, industry guidance, and company policy, while enabling the business to communicate effectively and competitively.
In addition to timely review of materials, the Associate Director/Director is expected to help shape messaging strategy early, anticipate regulatory risk and opportunities, and influence cross-functional partners to drive compliant, compelling communications that enable the business to deliver content and messaging effectively to its stakeholders.
Responsibilities
Strategic Regulatory Leadership
- Serve as the Ad Promo regulatory lead for assigned products (commercial and/or pipeline).
- Provide proactive guidance on promotional strategy, claims development, and risk positioning.
- Partner with Commercial, Medical, Legal, and Clinical teams to align messaging with labeling and data.
- Interpret and apply FDA regulations, OPDP guidance, enforcement trends, and industry standards to business initiatives.
- Assess regulatory risk and recommend clear, practical mitigation strategies.
Promotional Review & Governance
- Lead review and approval of prom