Global Program Regulatory Manager

Job Description Summary

The Global Program Regulatory Manager (GPRM) works with some independence under limited supervision, providing strategic and operational regulatory direction to assigned products. The GPRM may support the Global Program Regulatory Director (GPRD)/Global Therapeutic Area Lead (GTAL) for programs through development, registration and approval/post approval.
The GPRM also ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the GPRD/GTAL, and may in certain cases act as the Global Program Team (GPT) representative. The GPRM is a member of the RA subteam and may have responsibility for leading RA subteams.

 

Job Description

Major Accountabilities:

• Is responsible for implementing regulatory strategy and managing operational activities for assigned region (primarily USA).
• Provides input into global regulatory strategy including identification of gaps or risks in global strategic plan.
• Partners with local country organization to align on regulatory strategy in order to fulfill business objectives.
• Determines requirements and sets objectives for Health Authority (HA) interactions with RA GPT representative and/or GTAL.
• Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.
• Develops and implements plans for timely response to HA requests and coordinates responses.
• Serves as local HA liaison to FDA.
• Drives coordination, planning, and submission of dossiers in assigned regions worldwide.
• Review of global dossier summary documents.
• Develops and implements plans to avoid/minimize clock stops during submission review.

Key performance indicators:

• Successful implementation of global regulatory strategy for timely submissions and approvals with the best possible labels based on available data.
• Identification of main HA issues
• Successful Participation in HA interactions to achieve business objectives.
• Adherence to Novartis policy and guidelines, Project & stakeholder feedback

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

The pay range for this position at commencement of employment is expected to be between $124,000 - $186,000/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, 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.

Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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