Novartis Hiring for Global Program Regulatory Manager (Cardio-Renal-Metabolism) job in East Hanover Full Time

About the role
Location: East Hanover- Hybrid NJ #LI-Hybrid

The Global Program Regulatory Manager works with some independence under limited supervision to provide strategic and operational regulatory direction and may support the Regulatory Affairs Global Program Team (GPT) representative and/or Global Therapeutic Area Lead for programs through development, registration and approval/post approval. The GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the RA GPT representative and/or GTAL. In certain cases, the GPRM may act as the GPT representative. The GPRM is a member of the RA sub team and may indirectly report to the RA GPT representative for the project and may have responsibility for leading regional RA sub teams.

Key Responsibilities:
• Provide input into regulatory strategies and take responsibility for their subsequent implementation
• Manage operational activities for assigned projects and regions in accordance with applicable regulatory standards and within appropriate timeframes
• Represent Regulatory Affairs and lead sub-teams and/or cross-functional teams as required
• Lead or coordinate Health Authority meetings in assigned region(s)
• Contribute to the development of global and local labelling and review of promotional and non-promotional material in assigned region(s)
• Contribute to regulatory excellence by finding opportunities, mitigating risks and supporting continuous optimization and simplification
• Handle internal systems and tools that are needed to assess compliance

Commitment to Diversity & Inclusion:
We 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.

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

• Novartis: e-mail [email protected] or call +1 (877)395-2339
• Sandoz: e-mail [email protected] or call: +1-609-422-4098

Role Requirements
Essential Requirements:
• Science Based BSc or MSc. Advanced degree (MD, PhD, PharmD) preferred
• Experience with regulatory submission and approval processes in 1 or more major regions, as well as experience in a global/matrix environment or cross- functional teams in the pharmaceutical industry, and in Health Authority negotiations
• 2-4 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas: innovation in regulatory strategy; involvement in a dossier submissions and approvals; Health Authority negotiations; drug regulatory submission and commercialization in region; analysis and interpretation efficacy and safety data; understanding of post-marketing/brand optimization strategies and commercial awareness; regulatory operational expertise
• Strong interpersonal, communication, negotiation and problem solving skills with basic org awareness (e.g., interrelationship of departments, business priorities)

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

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.

The pay range for this position at commencement of employment is expected to be between $118,400 and $177,600/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, 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.

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