New

Regulatory Affairs Executive Director

Novartis Group Companies
parental leave, paid time off, sick time, 401(k)
United States, New Jersey, East Hanover
May 08, 2025
Job Description Summary The Executive Global Program Regulatory Director (Exec GPRD) provides expert global regulatory leadership throughout the lifecycle of an exceptionally complex project or a portfolio, requiring advanced expertise to navigate multifaceted organizational and asset complexities spanning multiple indications in one or more development units. The Exec GPRD is accountable for the assessment and regulatory strategy of due diligence assets. Using prior experience across multiple disease areas, the Exec GPRD acts as a thought-leader to create global regulatory strategy, including where there is limited or no precedence. By effectively managing stakeholders and steering cross-functional collaborations, and through impactful matrix leadership of highly functional regulatory sub-teams, the Exec GPRD ensures the organization's ability to deliver timely approvals of Novartis products with optimal product labeling to facilitate market access. The Exec GPRD may serve as a delegate for the RA Development Unit Head, extending their influence across broader strategic and operational decisions within the organization. Job Description Key Responsibilities: In collaboration with multiple stakeholders, develop, document and communicate high quality global regulatory strategies and lead Health Authority interactions to achieve optimal development and business objectives Evaluate and clearly communicate regulatory opportunities, develop contingencies for potential issues and ensure regulatory strategy across regions on all aspects of the assigned program/portfolio Lead execution of the regulatory strategy including submission planning, guidance to contributing authors and critical review of submission documentation including labeling and HA responses Lead interactions with RA and Development Unit management and with external consultants for strategic input and alignment on program development strategy and issue resolution Accountable for the assessment and design of regulatory strategies of complex external BD&L assets in close collaboration with the RA transactions team Represent RA on cross-functional excellence initiatives and task force teams for the resolution of cross-program issues Provide impactful matrix leadership of regulatory team(s) consisting of GPRDs and GPRMs and other team members from other RA line functions to drive cohesive strategies and achieve shared objectives Support sub-team members by providing meaningful feedback, coaching and mentorship, fostering their professional growth and enhancing overall team performance In partnership with the operational manager, identify and facilitate growth and development opportunities for sub-team, supporting a culture of continuous learning Champion Novartis culture, values and behaviors and demonstrate behaviors in action in-line with Novartis leadership expectations Essential Requirements: Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (e.g., MD, PhD, PharmD preferred. 12 years involvement in regulatory and pharmaceutical development Regulatory Strategy Expertise in the following areas: Analysis and interpretation of scientific data. Application of relevant concepts where no guidance or precedence exists. Experience in executing innovative regulatory strategies, and maximizing regulatory opportunities, whilst maintaining regulatory compliance. Challenging HA discussions and negotiations Regulatory submissions; prior experience as lead for major submissions. Post-marketing/brand optimization strategies and commercial savvy Demonstrated enterprise leadership and accomplishment across a broad range of global regulatory and pharmaceutical development activities and therapeutic areas. Matrix leadership, including demonstrated ability to provide feedback and coach sub-team members Role model for interpersonal, communication, influencing and problem-solving skills. Expertly navigates organizational complexity to achieve results The pay range for this position at commencement of employment is expected to be between $214,900 and $399,100 /year; however, while salary ranges are effective from 1/1/25 through 12/31/2025, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $214,900.00 - $399,100.00 Skills Desired Cross-Functional Teams, Drug Development, Global Clinical Trials, Lifesciences, Negotiation Skills, People Management, Problem Solving Skills, Program Management, Regulatory Compliance, Risk Management, Strategy