Regulatory Affairs Associate Director, CMC (f/m/d)

Regulatory Affairs Associate Director, CMC (f/m/d)

Location: Schaftenau, Austria

Work model: Hybrid

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.

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, 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.

Essential Requirements

• Fluency in English, written and spoken.
• Degree in a scientific discipline such as Chemistry, Pharmacy, Biochemistry, Biotechnology or Biology, or equivalent experience.
• Demonstrated capability in CMC Regulatory Affairs, including regulatory submission and approval processes.
• Strong understanding of CMC regulatory requirements and ability to 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.

Benefits & Rewards

In addition to a market-competitive base salary, Novartis offers an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group. The minimum salary stated in the collective bargaining agreement is €78,383.90 per year on a full-time basis. The primary location salary range is €88,300.00 - €164,100.00 per year.