Regulatory Affairs Associate Director, CMC

1d1 day ago

Novartis

Basel, CH · Full-time · CHF 160,000 – CHF 190,000

About this role

We are looking for a Regulatory Affairs Associate Director, CMC to contribute to the development and delivery of global Chemistry, Manufacturing and Controls (CMC) regulatory strategies across a portfolio of products. In this role, you will support regulatory activities across development and lifecycle stages, ensuring high-quality submission content and alignment with global regulatory requirements.

Working closely with cross-functional partners, you will help enable timely approvals and maintain compliant, consistent product information across markets. You will plan, coordinate, and support CMC submission activities, including authoring, review, and submission of documentation.

You will collaborate within a global matrix team environment, supporting consistent delivery and alignment on regulatory activities. The role involves communicating regulatory considerations, risks, and updates to cross-functional project teams and stakeholders.

You will contribute to continuous improvement initiatives and support knowledge sharing within the regulatory community. This role offers the opportunity to develop and implement global CMC regulatory strategies across a diverse product portfolio, while also supporting Health Authority interactions including preparation of briefing materials and responses.

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, organisational, and interpersonal skills, with a focus on quality, delivery, and continuous improvement.

Responsibilities

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, review, and submission of 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.
Contribute to and support Health Authority interactions, including preparation of briefing materials and responses.
Collaborate across functions to support consistent delivery and alignment on regulatory activities.
Contribute to continuous improvement initiatives and support knowledge sharing within the regulatory community.

Benefits

Hybrid work model offering flexibility between home and office.
Inclusive work environment with commitment to diversity and representation.
Reasonable accommodation support for medical conditions or disabilities throughout recruitment.