Global Program Regulatory Manager - Cardio-Renal-Metabolic

Novartis Farmacéutica; East Hanover (NJ); Hybrid; USD 114,000 - 212,000; Full time

Job summary

An established industry player is seeking a Global Program Regulatory Manager to provide strategic regulatory direction in the cardio-renal-metabolic area. This role involves working with cross-functional teams to ensure regulatory compliance and successful submissions for clinical trials. You will be instrumental in shaping regulatory strategies and leading interactions with health authorities. If you are passionate about making a difference in healthcare and possess a strong background in regulatory affairs, this is an exciting opportunity to join a collaborative and innovative environment.

Qualifications

• 2-4 years in regulatory and drug/biologic development activities.
• Experience with regulatory submission and approval in major regions.

Responsibilities

• Provide input to global program regulatory strategy.
• Lead planning, preparation, and submission of clinical trials.
• Ensure timely RA input and submission of compliance reports.

Skills

Clinical Trials

Detail Oriented

Drug Development

Negotiation Skills

Regulatory Compliance

Education

BS or MS in Science

MD, PhD, or PharmD

Job description

Global Program Regulatory Manager - Cardio-Renal-Metabolic

Job ID REQ-10043944

May 02, 2025

USA

Summary

The Global Program Regulatory Manager (GPRM) works with some independence under limited supervision to provide strategic and operational regulatory direction. The GPRM 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 aligned 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, with potential responsibility for leading regional RA sub-teams.

About the Role

#LI-Hybrid

Key Responsibilities

1. Regulatory Strategy
2. Provide input to global program regulatory strategy, including regulatory designations and innovative approaches.
3. Coordinate regulatory readiness with other functions, country organizations, and regions, representing Regulatory Affairs (RA) or leading in regional RA or cross-functional activities.
4. Contribute to the development and maintenance of key documents and determine requirements for Health Authority (HA) interactions.

Regulatory Submissions

1. Lead planning, preparation, and submission of clinical trials.
2. Implement the global registration strategy into regional submissions worldwide by country organizations.
3. Coordinate and prepare for submission of initial registrations and post-approval applications, including local product information.
4. Lead regulatory activities during HA reviews, responding to questions and interactions.

Regulatory Excellence & Compliance

1. Ensure timely RA input and submission of compliance and maintenance reports, maintaining regulatory information in databases and document systems.

Qualifications

• Science-based BS or MS with relevant experience; advanced degrees (MD, PhD, PharmD) preferred.
• Experience with regulatory submission and approval in major regions.
• Experience in global/matrix environments and cross-functional teams in pharma.
• Experience in HA negotiations.
• 2-4 years in regulatory and drug/biologic development activities (Phases I-IV), including regulatory strategy, dossier submissions, HA negotiations, and data analysis.

The pay range at start is $114,100 - $211,900/year, subject to adjustments based on various factors. The total package may include bonuses, stock, and benefits. Employment is at-will, with potential modifications to compensation.

Why Novartis: Helping people with disease takes more than science; it takes a passionate community. Join us to make a difference: https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Learn more at https://www.novartis.com/careers/benefits-rewards

Skills:

• Clinical Trials
• Detail Oriented
• Drug Development
• Negotiation Skills
• Regulatory Compliance

Join our Novartis Network to stay connected and find opportunities: https://talentnetwork.novartis.com/network

The Novartis Group of Companies is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other protected status.

Accessibility & Reasonable Accommodations

If you need accommodations for the application process or to perform job functions, contact [e-mail] or call [phone], including the job requisition number.

Division: Development

Business Unit: Universal Hierarchy Node

Location: USA, New Jersey, East Hanover

Company: Novartis Pharmaceuticals Corporation