Key Responsibilities:

• Serves as a primary regulatory advertising and promotion reviewer for assigned products on Materials Approval Process (“MAP”) teams, including launch products/indications, or complex and/or high-priority products
• Liaison with OPDP regarding advertising and promotion for assigned products, including products approved under Subpart H.  Establishes strong and positive working relationship with OPDP reviewers. Manages OPDP queries on assigned products.
• Applies regulatory and therapeutic area knowledge to Brand Team’s objectives and initiatives to develop solutions to complex US promotional issues. Ensures regulatory compliance while effectively managing business risks.
• Maintains awareness of competitive activities by monitoring major US Medical meetings where assigned therapeutic area products are promoted.
• Prepares complaint letters to OPDP.
• Conducts reviews of materials to be used by medical personnel in discussions with customers.
• Serves as Regulatory Affairs representative on cross-functional committees, task forces, etc.
• Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by OPDP, and by attendance of major FDLI, DIA and other industry/FDA meetings.
• Collaborates with other Regulatory Affairs colleagues to provide input to study designs or US label regarding feasibility of promoting potential data/claims.
• Participates in US labeling negotiations and FDA meetings as necessary.
• Ensures that changes in US Prescribing Information are reflected in current promotions and advertising.

Essential Requirements:

• BS Degree or equivalent.  Advanced degree desirable (MS, PhD, PharmD, or JD)
• Minimum 5 years regulatory experience in the pharmaceutical space
• In-depth knowledge and understanding of US regulations for drug promotion/advertising and US labeling
• Experience in leading activities for OPDP submissions, including time of first use sub-missions, requests for advisory comments, and 30-day submissions for Subpart H products
• Experience with regulatory activities involved in a product or indication launch
• Proven ability to analyze and interpret efficacy and safety data
• Understanding of business goals of the in-volved business franchise, marketing concepts and tools
• Must perform independently with strong negotiation and decision-making skills
• Must be able to work in a multi-disciplinary environment
• Proven analytical and problem-solving skills associated with problem review and inquiries and proven ability to provide creative solutions to complex problems

Novartis Compensation Summary:

The salary for this position is expected to range between $176,400 and $327,600 per 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.