Job Description Summary#LI-Hybrid
Location: East Hanover, United States
Relocation Support: This role is based in East Hanover, United States. Novartis is unable to offer relocation support: please only apply if accessible.
Company will not sponsor visas for this position.
Are you ready to shape the future of healthcare by guiding the regulatory strategy behind innovative medicines? As Sr. Director, Lead Regulatory Ad/Promo, you will lead a high-performing regulatory team within US Medical Affairs, influence key commercial and medical initiatives, provide trusted strategic guidance to senior stakeholders, and help ensure patients, healthcare professionals, and communities receive accurate and meaningful information about our therapies. This is an exciting opportunity to make a broad impact while partnering across functions to drive excellence, innovation, and regulatory leadership at Novartis.
Job DescriptionKey Responsibilities- Manages and provides regulatory oversight to a team of direct reports responsible for regulatory reviews and strategic advice relating to promotional activities and medical, nonpromotional materials for assigned brands/franchises.
- Guides, coaches, and develops direct reports on personal growth opportunities, organizational impact, and professional development.
- Partners with commercial and medical functions on cross-functional committees, task forces, and other forums to provide strategic regulatory advice aligned with business goals and objectives, FDA regulations/guidances, PhRMA guidelines, and company policy.
- Applies regulatory and industry knowledge to business initiatives, developing solutions to navigate complex U.S. regulatory standards for promotional and select medical activities.
- Ensures regulatory compliance while effectively identifying, assessing, and managing business risks.
- Maintains awareness of competitive activities by monitoring major U.S. medical meetings where assigned therapeutic area products are promoted.
- Collaborates with cross-functional colleagues to provide regulatory input on study designs and U.S. labeling, including assessment of the feasibility of promoting potential data and claims.
- Participates in U.S. labeling negotiations and FDA meetings, as appropriate, to support regulatory strategy and business objectives.
- Serves as the regulatory advertising and promotion reviewer and/or regulatory representative on medical teams for assigned disease areas, products, launch indications, and other complex or high-priority programs.
- Models and promotes effective AI use across the team by embedding AI tools into workflows, guiding responsible AI practices, and fostering a culture of experimentation, innovation, and continuous learning.
Essential Requirements- BS Degree or equivalent required.
- Minimum 7 years of regulatory experience, including in-depth knowledge of U.S. regulations governing drug promotion/advertising and U.S. labeling.
- Experience leading activities for OPDP submissions, including time of first use submissions, requests for advisory comments, and 30-day submissions for Subpart H products.
- Experience supporting regulatory activities associated with product and/or indication launches.
- Proven ability to analyze and interpret efficacy and safety data and apply insights to regulatory decision-making.
- Strong understanding of business goals, marketing concepts, and tools, with the ability to work independently using sound negotiation and decision-making skills.
- Demonstrated interpersonal, communication, analytical, and problem-solving skills, with the ability to work effectively in a multi-disciplinary environment.
Desirable Requirements- Advanced degree preferred (MS, PhD, PharmD, or JD).
- Experience leading a team of regulatory professionals and managing/directly developing people preferred.
Novartis Compensation SummaryThe pay range for this position at commencement of employment is expected to be between $176,400 - $327,600 year.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
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Salary Range$176,400.00 - $327,600.00
Skills DesiredClinical Trials, Drug Development, People Management, Regulatory Compliance, Risk Management, Strategy Execution
