Novartis Hiring for Global Program Regulatory Manager/Sr GPRM (Global Health) job in East Hanover Full Time

Job Description
Location: East Hanover, NJ #LI-Hybrid

About the Role:
The Sr Global Program Regulatory Manager will work independently 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 (GTAL) for programs through development, registration and approval/post approval. The Sr GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the RA global program team (GPT) representative and/or GTAL. In certain cases, the GPRM may be the GPT representative. The Sr GPRM is a member of the RA sub team and may indirectly report to the RA GPT representative for the project and has responsibility for leading regional RA sub teams.

Key Responsibilities:
Provide input into global regulatory strategies and implement in assigned regions (focus US/LaCan) in collaboration with local teams
• Act as FDA liaison for assigned products
• Represent Regulatory Affairs and lead regulatory and cross-functional sub-teams
• Lead or coordinate Health Authority meetings
• Contribute to the development of global and local labeling and review of promotional and non-promotional material
• Ensure regulatory compliance, e.g. keep records of relevant Health Authority interactions in document management system and compliance databasesMinimum requirements
Essential Requirements:
• Science based BS or MS. Advanced degree (MD, Ph D, PharmD) preferred
GPRM: 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
• Sr. GPRM: 4-6 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV, including experience in leading regulatory submissions and approvals in at least 1 major region
• Experience in a global/matrix environment or cross functional teams in the pharmaceutical industry
• Strong interpersonal, communication, negotiation and problem solving skills
• Proven ability to analyze and interpret efficacy and safety data

Why Novartis:
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/peopleandculture

The pay range for this position at commencement of employment is expected to be between GPRM: $118,400 and $177,600 & Sr. GPRM: $158,400 and $237.600/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.

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

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 in order to perform the essential functions of a position, please send an e-mail to [email protected] 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.
https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities. Join the Novartis Network here: https://talentnetwork.novartis.com/network