Regulatory Affairs Manager/Senior Manager, CMC

Summary

#LI-Hybrid

Location: East Hanover, NJ

This role is required to be in our East Hanover, NJ office 3x/week.

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

We are looking for an experienced Senior Manager, Regulatory Affairs CMC to lead global regulatory strategy and execution across the product lifecycle. In this role, you will drive the development, submission, and approval of CMC dossiers, ensuring compliance with regulatory requirements while supporting timely access to innovative medicines for patients worldwide.

Working within a global, crossfunctional environment, you will provide strategic direction, manage regulatory risks, and act as a key interface with health authorities.

About the Role

Major Accountabilities

• Lead and implement global CMC regulatory strategies for assigned products and projects.
• Plan, author, review, and coordinate highquality regulatory submissions.
• Ensure regulatory compliance, technical accuracy, and alignment with global guidelines.
• Identify risks, develop mitigation plans, and communicate key issues to stakeholders.
• Collaborate across crossfunctional teams to support product development and lifecycle management.
• Lead interactions with health authorities, including preparation and coordination of submissions and responses.
• Support due diligence activities for business development opportunities.

Essential Requirements

• 5+ years of experience in regulatory affairs and/or the pharmaceutical industry.
• Understanding of regulatory submission and approval processes.
• Knowledge of chemistry, biotechnology, analytics, or pharmaceutical technology, with the ability to evaluate scientific data from a range of disciplines.
• Experience working collaboratively in crossfunctional or global teams, with the ability to manage and prioritise multiple activities.
• Ability to work independently as well as contribute effectively within team environments.
• Strong planning, organisational, and communication skills.
• Confidence using digital tools and systems relevant to the role.

Benefits & Rewards

The salary for this position is expected to range between $119,700 and $223,300 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

To learn more about the culture, rewards and benefits we offer our people click here.

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?