344360BR
Apr 25, 2022
USA

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. Novartis Institutes for Biomedical Research (NIBR) is world renowned for its groundbreaking science in drug development including cell and gene therapies. RA plays a critical role planning first-in-human strategies through development decision point and long-term project strategy. We work closely with NIBR scientists on innovative medicines for diseases with a high unmet medical need. Read on to learn about the role available in Regulatory Affairs. We hope you will consider joining our global OneRA family.

Your responsibilities will include, but are not limited to:

• Providing input into regulatory strategies and taking responsibility for their subsequent implementation.
• Managing operational activities for assigned projects and regions in accordance with applicable regulatory standards and within appropriate timeframes.
• Representing Regulatory Affairs and leading sub-teams and/or cross-functional teams as required
• Health Authority interactions.
• Contributing to regulatory excellence by finding opportunities, mitigating risks and supporting continuous optimization and simplification.
• Handling our internal systems and tools that are needed to assess compliance

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’ll bring to the role:
• BSc or MSc. Advanced degree (MD, PhD, PharmD) preferred.
• Experience with regulatory submission and approval processes in 1 or more major regions, including mandatorily the United States Food and Drug Administration (FDA).
• 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.
• Understanding of post-marketing strategies and commercial awareness
• Strong interpersonal, communication, negotiation and problem solving skills; basic organizational awareness (e.g., interrelationship of departments, business priorities)

Desirable requirements:
• Basic understanding how to interpret efficacy and safety data

Why consider Novartis?

766 million lives were touched by Novartis medicines in 2021, 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.

Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:

https://talentnetwork.novartis.com/network

Vaccine Policy:

While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected]

Global Drug Development
REG AFFAIRS GDD
USA
Cambridge, MA
Research & Development
Full Time
Regular
No
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344360BR

Sr. Gbl Program Regulatory Manager (Assoc. Director)-Early Development

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