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.
What You'll Do
The Senior Director/Executive Director, Regulatory Affairs Advertising and Promotion, will serve as the strategic and operational leader providing regulatory oversight, review, and direction for pharmaceutical product advertising and promotion. This person is responsible for compliance with regulatory requirements while meeting the Company's strategic promotional objectives. This role partners closely with cross-functional teams, including Affiliates, Commercial, Legal, Medical Affairs, and Corporate Communications.
Responsibilities
Strategic Leadership
- Lead the development and implementation of regulatory advertising and promotion strategies for preapproval and marketed products across therapeutic areas
- Serve as the primary reviewer, or provide oversight of the primary Regulatory Affairs representative(s) on promotional Medical/Legal/Review (MLR) committees, ensuring clear guidance and timely feedback to internal stakeholders
- Partner with senior Commercial and Legal leaders to align promotional initiatives with evolving FDA and OPDP requirements
- Ensure a strategic lens is leveraged in regulatory reviews to balance the business needs
Regulatory Review & Compliance
- Provide interpretation of FDA regulations, guidance documents, and enforcement actions related to promotional labeling, advertising, and digital communications
- Oversee the review and approval of promotional materials, ensuring scientific accuracy, fair balance, and alignment with approved labeling
- Provide training initiatives on regulatory promotional compliance and regulatory principles
- Establish work instructions and SOPs for regulatory advertising and promotion
Agency and Health Authority Interactions
- Serve as the regulatory point of contact for FDA’s Office of Prescription Drug Promotion (OPDP)
- Prepare and lead responses to FDA requests or inquiries on advertising and promotional matters
- Monitor enforcement trends and emerging regulations, proactively adjusting company strategies and SOPs as needed
Leadership & Talent Development
Where You'll Work
This is a hybrid role based either in San Francisco, Washington, D.C., Remote will also be considered.
Who You Are
- Advanced degree in a scientific discipline (PharmD, PhD, or MD) required
- 15+ years of progressive regulatory experience in the biopharmaceutical industry, with at least 10 years focused on pharmaceutical advertising and promotion
- Demonstrated expertise in using regulatory systems (e.g., Veeva Vault, RIM) and developing process governance frameworks (SOPs, WIs, desk procedures)
- Track record of leading or enabling digital transformation or AI integration within regulatory or adjacent functions
- Exceptional leadership, communication, and influencing skills, with the ability to operate effectively in a matrixed, fast-paced environment
Rewarding Those Who Make the Mission Possible
We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
Financial Benefits:
- Market leading compensation
- 401K with 100% employer match on first 3% & 50% on the next 2%
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with $2,500 award for hired referrals
Health & Wellbeing:
- Comprehensive health care with 100% premiums covered - no cost to you and dependents
- Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
- Hybrid work model - employees have the autonomy in where and how they do their work
- Unlimited flexible paid time off - take the time that you need
- Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
- Flex spending accounts & company-provided group term life & disability
- Subsidized lunch via Forkable on days worked from our office
Skill Development & Career Paths:
- People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
- We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
- We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities