Regulatory Affairs Executive Director

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 thoughtleader to create global regulatory strategy including where there is limited or no precedence. By effectively managing stakeholders and steering crossfunctional collaborations and through impactful matrix leadership of highly functional regulatory subteams the Exec GPRD ensures the organizations 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 crossfunctional excellence initiatives and task force teams for the resolution of crossprogram 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 subteam 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 subteam supporting a culture of continuous learning
• Champion Novartis culture values and behaviors and demonstrate behaviors in action inline 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.
• Postmarketing/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 subteam members
• Role model for interpersonal communication influencing and problemsolving skills.
• Expertly navigates organizational complexity to achieve results

The pay range for this position at commencement of employment is expected to be between $214900 and $399100 /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 signon 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 atwill 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 and Rewards: Read our handbook to learn about all the ways well help you thrive personally and professionally: 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 email to or call 1(877)and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$214900.00 $399100.00

Skills Desired

CrossFunctional Teams Drug Development Global Clinical Trials Lifesciences Negotiation Skills People Management Problem Solving Skills Program Management Regulatory Compliance Risk Management Strategy