Regulatory Affairs Associate Director, CMC

Novartis seeks an Associate Director for Regulatory Affairs, CMC in Basel to lead global regulatory strategies and submission activities for its product portfolio.

The company is looking for a professional to drive global Chemistry, Manufacturing and Controls (CMC) regulatory strategies across its product range. This position ensures that all development and lifecycle stages meet high-quality standards and align with international regulatory expectations.

Responsibilities

• Develop and execute global CMC regulatory strategies for specific projects.
• Manage the planning, coordination, and execution of CMC submission activities, including writing and reviewing documentation.
• Determine documentation needs and ensure stakeholder alignment on content quality and schedules.
• Create and assess CMC regulatory documents to guarantee adherence to relevant guidelines.
• Share regulatory risks, updates, and considerations with cross-functional teams.
• Prepare briefing materials and responses for interactions with Health Authorities.
• Work with various departments to ensure consistent regulatory activity delivery.
• Participate in continuous improvement efforts and facilitate knowledge sharing within the regulatory team.

Requirements

• Fluent proficiency in English, both written and spoken.
• A degree in a scientific field such as Chemistry, Pharmacy, Biochemistry, Biotechnology, or Biology, or equivalent professional experience.
• Proven experience in CMC Regulatory Affairs, including handling submission and approval workflows.
• Deep understanding of CMC regulatory requirements and the ability to navigate complex topics to inform strategy.
• Capability to analyze scientific data from multiple disciplines and apply insights to regulatory decisions.
• Practical knowledge of pharmaceutical development, manufacturing processes, or related scientific areas.
• Strong collaboration and influence skills within global, cross-functional matrix teams while managing competing priorities.
• Excellent planning, organizational, and interpersonal abilities with a focus on quality and continuous improvement.

About the company

Novartis is dedicated to fostering an inclusive work environment and building diverse teams that reflect the patients and communities it serves.

• Commitment to an outstanding and inclusive workplace culture.
• Focus on building diverse teams representative of patients and communities.