[Remote] Sr. Director/Executive Director, Advertising and Promotion

Note: The job is a remote job and is open to candidates in USA. BridgeBio is a biopharmaceutical company focused on developing life-changing medicines for patients with unmet needs. The Senior Director/Executive Director of Advertising and Promotion will lead regulatory oversight and strategy for pharmaceutical product advertising, ensuring compliance with regulatory requirements while partnering with cross-functional teams. Responsibilities • 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 • 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 • 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 • Hire, coach, and mentor regulatory professionals supporting advertising and promotion activities Skills • 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 Benefits • 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 • 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 • 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 • At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Company Overview • BridgeBio focuses on the development and commercialization of precision medicines for various genetic diseases and cancers. It was founded in 2015, and is headquartered in Palo Alto, California, USA, with a workforce of 201-500 employees. Its website is http://bridgebio.com. Company H1B Sponsorship • BridgeBio has a track record of offering H1B sponsorships, with 2 in 2025, 5 in 2024, 4 in 2023, 4 in 2022, 1 in 2021, 2 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job Apply To this Job