Job Posting Title Regulatory Affairs Associate Director, CMC

Job Description Summary

#LI-Hybrid
Location: Schaftenau, Austria

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.

 

Job Description

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 (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.

 

Skills Desired