Regulatory Affairs Project Manager Life Cycle Management

About the Opportunity

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia, and the Americas.

We are currently seeking an experienced Regulatory Affairs Project Manager to support operational Life Cycle Management (LCM).

Responsibilities

• Lead and manage global regulatory LCM activities, including planning and coordination of submissions.
• Support and liaise with local partners worldwide for submission of variations and related administrative tasks.
• Ensure regulatory compliance in accordance with global and regional requirements.
• Collaborate cross-functionally to gather documentation and align on regulatory strategy and timelines.

About You

Proven experience in regulatory affairs, specifically in Life Cycle Management and global post-approval submissions.

Ability to work independently and drive activities forward with minimal oversight.

Strong project management and communication skills.

Available for an immediate start or short notice.

Willingness to travel to Lugano, Switzerland for a few days for onboarding and activity alignment (travel expenses covered).

English language: Fluent written and spoken (at least B2 level)

Italian language: Fluent written and spoken (at least B2 level)

Remote work is the default mode.

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive outcome coming from the Hiring Manager interview, the recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills, and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.