โMineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Blueskyโ
Mineralys is a fully remote company.
The Senior Director, Advertising & Promotion, Regulatory Affairs (Ad & Promo) will lead all regulatory activities related to medical and promotional material development, review, and external communications for Mineralys as it advances toward commercialization. This individual will 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.
This is a highly visible, hands-on role ideal for a strategic, detail-oriented, and collaborative regulatory leader who thrives in a fast-moving, small-company environment and is comfortable building Ad & Promo infrastructure under launch timelines.
Key Responsibilities
Strategic Leadership
- Serve as the Regulatory lead on the MLR team, providing 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.
MLR Review and OPDP Interactions
- 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.
Cross-Functional Leadership
- 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.
Qualifications
Education & Experience
- Bachelorโs 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.
Skills & Competencies
- 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.
Travel
This position has approximately 10% travel. Frequently travel is outside the local area and overnight.
These positions are eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level.
US Salary Range: $275,000 - $290,000
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