Regulatory Affairs Manager/Senior Manager, CMC

Job Description 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, cross‑functional environment, you will provide strategic direction, manage regulatory risks, and act as a key interface with health authorities. Job Description Major Accountabilities Lead and implement global CMC regulatory strategies for assigned products and projects. Plan, author, review, and coordinate high‑quality 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 cross‑functional 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 cross‑functional 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. EEO Statement: 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 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 to perform the essential functions of a position, please send an e-mail to View email address on click.appcast.io or call View phone number on click.appcast.io and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $119,700.00 - $222,300.00 Skills Desired Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .