Regulatory Compliance Specialist

For our client based in Aubonne, we are currently looking for a Regulatory Compliance Specialist for a 12-month contract.

Your role:

As a Regulatory Compliance Specialist, you will ensure that local manufacturing activities and GMP documentation remain fully aligned with regulatory filings.

• You will assess and manage change controls, ensuring timely and accurate reporting to Health Authorities.

• You will review and approve GMP documents, ensuring compliance with regulatory submissions and marketing authorizations.

• You will coordinate regulatory deliverables to support submissions and responses to Health Authorities, including technical writing and maintaining the Site Master File.

• You will act as a local point of contact for Regulatory Affairs CMC and Health Authorities, providing expertise and guidance.

• You will support inspection readiness, regulatory intelligence monitoring, and the continuous improvement of compliance processes.

• You will collaborate with internal functions, global regulatory teams, and external stakeholders to ensure seamless alignment and compliance.

Your work will directly impact regulatory compliance at site level, continuous improvement of processes, and the timely implementation of changes in a highly regulated environment.
 

Your profile:

• Degree in Life Sciences (Biology, Pharmacy, or related field).

• Relevant experience in biotechnological manufacturing and interaction with regulatory agencies.

• Strong knowledge of GMP, GxP systems, and regulatory guidelines.

• Proven expertise in regulatory affairs and the ability to interpret regulatory intelligence.

• Excellent communication and editorial skills.

• Fluent in English and French (a third European language would be an asset).

• Collaborative, results-driven, and future-oriented mindset with the ability to work autonomously.