345707BR
May 25, 2022
USA

Job Description

583! That is the total number of projects and products on our Global Regulatory Affairs CMC project list. All of these innovative projects are aimed at making a difference in patients’ lives and we need your help. As a senior member of our Global Regulatory Affairs CMC team, your role would be to establish and drive global CMC regulatory strategic and operational direction and documentation for complex projects and products covering development, registration and approval/post approval activities.

Your Responsibilities include but are not limited to:
• Formulate, lead and drive global CMC regulatory strategy for Biologics projects/products drawing on extensive regulatory expertise with a focus on innovation, maximizing the business benefit balanced with regulatory risks and compliance.
• Lead and drive all global CMC submission activities (planning, authoring, reviewing, coordination,
submission) for assigned projects/products, while applying the global strategy into submissions.
• Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
• Author and/or review high-quality CMC documentation for Health Authority submissions, establishing
and applying CMC global regulatory strategies, current regulatory trends and guidelines.
Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and epublishing
requirements.
• Represent Global Regulatory CMC on cross-functional project teams and maintain collaborative
partnerships with stakeholders.
• Initiate and lead Health Authority interactions and negotiations including more complex interactions;
setting objectives, preparing briefing books, coordinating and planning rehearsals and risk
mitigation plans. Establish and maintain a single point of contact with FDA.
• Act as a role model, providing strategic advice within and outside of RA CMC, driving continuous
improvement and building the talent within the team through coaching and mentoring.

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:

Education Minimum: Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Molecular Biology,
Biotechnology, Biology) or equivalent; advanced degree desired
• Minimum 10 years regulatory experience preferred and/or pharmaceutical industry experience
• Extensive knowledge/experience in regulatory submission and approval processes and ability
to solve complex CMC regulatory issues and requirements.
• Proven ability to critically evaluate data from a broad range of scientific disciplines.
• Demonstrated track record to successfully lead/work in interdisciplinary global teams; leading,
planning, and prioritizing activities simultaneously on multiple projects
• Demonstrated ability for innovative and big picture thinking.
• Strong planning, negotiation, organizational and interpersonal skills.
• Excellent written/spoken communication, and negotiation skills

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

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.

https://www.novartis.com/careers/careers-research/notice-all-applicants…

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
Global Drug Development
REG AFFAIRS GDD
USA
East Hanover, NJ
Research & Development
Full Time
Regular
No
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345707BR

Regulatory Affairs CMC Director (Biologics)

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