Senior Global Program Regulatory Manager (Early Development) - Associate Director Level

Novartis Farmacéutica; Cambridge (MA); On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player seeks a Senior Global Program Regulatory Manager to provide strategic direction and manage regulatory activities for major regions. This role involves negotiating with regulatory agencies, developing plans for timely responses, and ensuring compliance throughout the product lifecycle. Join a collaborative team dedicated to improving patient outcomes through innovative solutions. If you're passionate about regulatory affairs and want to make a significant impact in the pharmaceutical industry, this opportunity is perfect for you.

Qualifications

• 4-6 years in regulatory and drug/biologic development.
• Strong knowledge of regulatory submission processes.

Responsibilities

• Implement regulatory strategy and manage operational activities.
• Drive coordination and submission of dossiers worldwide.

Skills

Clinical Trials

Cross-Functional Teams

Detail Oriented

Drug Development

Negotiation Skills

Problem Solving Skills

Regulatory Compliance

Education

Science based BS or MS

Advanced degree (MD, PhD, PharmD)

Job description

Senior Global Program Regulatory Manager (Early Development) - Associate Director Level

Job ID REQ-10048241

Apr 16, 2025

USA

Summary

Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle.

About the Role

Key Responsibilities:

• Is responsible for implementing regulatory strategy and managing operational activities for assigned major/ large regions.
• Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.
• Determines requirements and sets objectives for Health Authority (HA) interactions with DRA 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.
• May serve as local HA liaison depending on location (e.g., FDA or EMA).
• Drives coordination, planning, and submission of dossiers in assigned regions worldwide.
• Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).
• Contributes to and often leads the development of departmental goals and objectives.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
• Science based BS or MS with requisite experience and (Minimum/desirable): demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.
• Strong knowledge of regulatory submission and approval processes in 1 or more major regions.
• Experience 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. Experience in HA negotiations.
• 4-6 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas:
• Innovation in regulatory strategy.
• Prior history with post-marketing/brand optimization strategies and commercial awareness preferred.
• Involvement in dossier submissions and approvals. HA negotiations.
• Drug regulatory submissions and commercialization in major regions.
• Proven ability to analyze and interpret efficacy and safety data.
• Regulatory operational expertise.

Skills:

• Clinical Trials.
• Cross-Functional Teams.
• Detail Oriented.
• Drug Development.
• Negotiation Skills.
• Problem Solving Skills.
• Regulatory Compliance.

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? Learn more.

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Learn more.

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

Division Development

Business Unit Innovative Medicines

Location USA

State Massachusetts

Site Cambridge (USA)

Company / Legal Entity U014 (FCRS = US014) Novartis Pharmaceuticals Corporation