Regulatory Affairs Executive Director

Novartis • East Hanover, NJ

231d • $214,900 - $399,100

About The Position

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.

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.

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.

Benefits

• Full range of medical benefits.
• Financial benefits including 401(k) eligibility.
• Various paid time off benefits, such as vacation, sick time, and parental leave.
• Sign-on bonus.
• Restricted stock units.
• Discretionary awards.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Master's degree