Regulatory Affairs Senior Manager, CMC

Novartis • East Hanover, NJ

1d • $119,700 - $223,300 • Hybrid

About The Position

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.

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.

Nice To Haves

• Change Control
• Cross-Functional Teams
• Documentation Management
• Negotiation Skills
• Regulatory Compliance
• Risk Assessment
• Risk Management
• Waterfall Model

Responsibilities

• 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.

Benefits

• performance-based cash incentive
• annual equity awards
• health, life and disability benefits
• 401(k) with company contribution and match
• generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed