Regulatory Affairs Senior Manager, CMC

• 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.

• 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.