Senior Director, Advertising and Promotion – Regulatory Affairs
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Job Description
Lead regulatory activities for promotional material development at Mineralys Therapeutics. Oversee compliance with FDA regulations and collaborate with cross-functional teams in a fast-paced environment.
Responsibilities:
- Lead all regulatory activities related to medical and promotional material development, review, and external communications for Mineralys as it advances toward commercialization.
- Serve as the primary regulatory representative on the Medical, Legal and Regulatory (MLR) team, ensuring that all promotional, non-promotional and scientific exchange materials adhere to internal policies, relevant laws, FDA regulations, and industry standards.
- Provide timely, compliant strategic guidance for all promotional and non-promotional materials development.
- Interpret and apply FDA Advertising & Promotion regulations, guidance, OPDP expectations and enforcement trends, to company materials.
- Serve as a strategic thought partner with Marketing and Medical Affairs to develop compliant and compelling promotional and medical strategy and framework ahead of launch.
- Collaborate cross-functionally with Medical Affairs, Commercial, Legal, Clinical Development, and agency partners on messaging and claims substantiation.
- Provide regulatory guidance on digital and omnichannel content, including modular content, rapid update scenarios, and social media platforms.
- Review all relevant materials, including but not limited to digital and print assets, HCP and patient-facing materials, disease awareness, sales training, company-controlled medical education, press releases, social media, and investor communications (as appropriate) to ensure compliance.
- Partner with Marketing Operations to ensure seamless MLR execution, workflow design, SOPs, timelines, and cross-functional coordination.
- Lead interactions with OPDP, including advisory comments, submissions, and correspondence.
- Orchestrate promotional audits and monitoring, and corrective actions as appropriate.
- Monitor and interpret regulatory developments related to Advertising & Promotion and proactively update the organization regarding implications.
- Support internal training on Advertising & Promotion requirements.
- Build strong relationships across Medical, Legal, Commercial, Clinical, and Compliance functions, providing balanced solutions-oriented guidance.
- Facilitate discussions around regulatory risk tolerance and best practices to enable compliant and competitive brand execution.
Requirements:
- Bachelor’s degree required; advanced scientific degree (PharmD, PhD, JD, or MS) preferred.
- 8+ years regulatory experience, including 5+ years in Ad & Promo within the biopharmaceutical industry.
- Direct experience leading U.S. regulatory review of promotional materials and interfacing with OPDP; global experience a plus.
- Launch and pre-launch experience is strongly preferred.
- Deep knowledge of FDA regulations (21 CFR Parts 201, 202, and applicable postmarketing submission requirements), promotional guidance including CFL, and enforcement trends.
- Strong scientific understanding of clinical data with the ability to interpret, analyze, and translate complex findings into compliant messaging.
- Demonstrated ability to collaborate cross-functionally and influence stakeholders without direct authority.
- Exceptional communication skills; able to deliver clear, concise, and actionable guidance.
- Comfort working in a small, fast-paced, matrixed biotech environment.
- Ability to balance scientific accuracy, commercial objectives, and regulatory risk.
- Experience supporting DTC and HCP campaigns.
- Ability to work independently with minimal oversight.
Benefits:
- medical
- dental
- vision
- time off
- 401K
- participating in Mineralys incentive plans are contingent on achievement of personal and company performance
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