Sr. Global Program Regulatory Manager (Associate Director level)

Job Description

1,800+ associates. 86 countries. One Regulatory Affairs. At Novartis your voice, experience, and quality mindset can truly make a difference in Regulatory Affairs (RA). Novartis has a unique and promising portfolio with 70 projects as potential NMEs in development, 65 projects in Phase 3 or already undergoing registration, and 100 Phase 1/2 projects. We also focus on rare disease areas; in fact, more than 80% of our innovation is targeted on areas of high unmet need. In many cases, we can offer family friendly work flexibility to facilitate your physical and mental health. Read on to learn about the role available in Regulatory Affairs. We hope you will consider joining our global OneRA family.

The Sr Global Program Regulatory Manager (Life Cycle Management) will work independently 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 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.

Your responsibilities will include, but are not limited to:

• Implementing regulatory strategy and managing operational activities for a portfolio of products
• Independently managing preparation of regulatory submissions (e.g. Annual, aggregate safety reports, renewals, variations, etc.) for assigned portfolio
• Representing Regulatory Affairs and leading sub-teams and/or cross-functional teams as required for timely preparation of regulatory documents and serving as a primary contact with FDA for assigned portfolio of products
• Ensuring necessary updates and reviews of the prescription information and to maintain consistency with the CDS in collaboration with Global Labeling
• May serve as Regulatory Affairs subject matter expert
• May contribute to training and mentoring regulatory associates
• Contributing to portfolio streamlining activities e.g., pruning and de-registration, divestment - and drug shortage notifications
• Contributing to regulatory excellence by finding opportunities, mitigating risks and supporting continuous optimization and simplification

Diversity & Inclusion / EEO

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.

Minimum Requirements

What you will bring to the role:

• BSc or MSc. Advanced degree (MD, PhD, PharmD) preferred
• Experience leading regulatory submissions and approvals in at least 1 major region
• At least 2 years involvement in regulatory affairs and drug development preferably 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 multiple areas, including:
o Innovation in regulatory strategy.
o Prior history with post-marketing/brand optimization strategies and commercial awareness preferred.
• Understanding of post-marketing strategies and commercial awareness
• Understanding of how to interpret efficacy and safety data
• Strong interpersonal, communication, negotiation and problem solving skills; basic organizational awareness (e.g., interrelationship of departments, business priorities)

Why consider Novartis?

736 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. 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 $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

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.

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