Novartis Pharma AG - May 31, 2026

Job ID

REQ-10078161

Date: May 15, 2026

Location: Basel, Switzerland

Summary

#LI-Hybrid

We are seeking a Regulatory Affairs Associate Director, CMC to play a key role in the development and delivery of global Chemistry, Manufacturing and Controls (CMC) regulatory strategies across a diverse portfolio of products.

About the Role

In this pivotal position, you will support regulatory activities throughout both development and lifecycle stages, ensuring the creation of high-quality submission content that aligns with global regulatory requirements. By working closely with cross-functional partners, you will facilitate timely approvals and maintain consistent, compliant product information across markets.

Major Accountabilities

Contribute to the development and implementation of global CMC regulatory strategies for assigned projects and products.
Plan, coordinate, and support CMC submission activities, including authoring, reviewing, and submitting documentation.
Identify documentation requirements and manage alignment on content, quality, and timelines across stakeholders.
Author and review high-quality CMC regulatory documentation, ensuring compliance with applicable guidelines and standards.
Communicate regulatory considerations, risks, and updates to cross-functional project teams and stakeholders.
Prepare briefing materials and responses for Health Authority interactions.
Collaborate across functions to ensure consistent delivery and alignment on regulatory activities.
Support continuous improvement initiatives and share knowledge within the regulatory community.

Essential Requirements

Fluency in English (written and spoken).
Degree in a scientific discipline (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent experience.
Demonstrated capability in CMC Regulatory Affairs, including regulatory submission and approval processes.
Strong understanding of CMC regulatory requirements, with the ability to navigate complex regulatory topics and contribute to regulatory strategy.
Ability to evaluate scientific data across multiple disciplines and translate insights into regulatory decision-making and documentation.
Working knowledge of pharmaceutical development, manufacturing, or related scientific areas.
Ability to collaborate effectively and influence within cross-functional, global matrix teams while managing multiple priorities.
Strong planning, organizational, and interpersonal skills, with a focus on quality, delivery, and continuous improvement.

Commitment to Diversity and Inclusion

Novartis is dedicated to building an inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Accommodation

At Novartis, we are committed to providing reasonable accommodations for individuals with medical conditions or disabilities. If you need support during the recruitment process, please reach out to inclusion.switzerland@novartis.com. Be sure to include the job requisition number in your message.

Why Novartis

Helping people with diseases and their families requires more than innovative science; it takes a community of passionate individuals like you. Join us in collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? Learn more about us here.

Benefits and Rewards

Discover the many ways we will support your personal and professional growth. For more details, please read our handbook (PDF 30 MB).

Application Process

Apply online using the form below. Please note that only applications matching the job profile will be considered.

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