Global Program Regulatory Manager (Remote)

Job Description Summary

The Global Program Regulatory Manager (GPRM) works with some independence under limited supervision to provide strategic and operational regulatory direction and may support the RA global program team (GPT) representative and / or Global Therapeutic Area Lead (GTAL) 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.

Job Description

#LI-Remote

Key Responsibilities :

Regulatory Strategy

• Provide input to global program regulatory strategy, including regulatory designations & innovative approaches
• Coordinates regulatory readiness with other line functions, Country Organizations & Regions, representing Regulatory Affairs (RA) or leads in regional RA or cross-functional activities providing strategic input into cross functional deliverables
• Contributes to the development and maintenance of key documents, determines the requirements and coordinates the activity for Health Authority (HA) interactions

Regulatory Submissions

Regulatory Excellence & Compliance

Essential Requirements :

Innovation in regulatory strategy | Understanding of post-marketing / brand optimization strategies and commercial awareness preferred | Involvement in an dossier submissions and approvals | HA negotiations | Drug regulatory submission and commercialization in region | Analysis and interpretation efficacy and safety data | Regulatory operational expertise | Strong interpersonal, communication, negotiation and problem solving skills | Basic organizational awareness (e.g., interrelationship of departments, business priorities).

The ideal location for this role is the East Hanover, NJ site but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel / lodging to specific site (East Hanover, NJ) for periodic live meetings will be at the employee's expense. The expectation of working hours and travel (domestic and / or international) will be defined by the hiring manager.

The pay range for this position at commencement of employment is expected to be between $114,100 and $211,900 / 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 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.

EEO 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 e-mail to or call and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$114,100.00 - $211,900.00

Skills Desired

Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance