WE SAVE LIVES WORLDWIDE; WOULD YOU LIKE TO JOIN US?

We are looking for a specialist preferably with knowledge of CMC and regulatory life-cycle management (LCM) activities for biological products. We invite both recently graduated or more experienced who have an interest in CMC and / or Regulatory Life Cycle Management, to apply.

THE TEAM’S RESPONSIBILITIES AND AMBITIONS

Regulatory Affairs is responsible for global regulatory activities throughout the life cycle of our products in more than 50 countries worldwide. We work closely together with our colleagues across functions and with our partners and consultants.
We strive to be responsive to the worldwide business needs of AJ Vaccines A/S and to minimize time to market, while ensuring compliance in a continuously changing global regulatory environment.
You will get the opportunity to work in a team of highly competent and dedicated colleagues, who have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders.

YOUR WORK TASKS

As a part of Global Regulatory Affairs at AJ Vaccines A/S, you will be working with CMC and LCM activities for our biological products. You will be engaged in the regulatory interactions concerning scientific issues with partners and Health Authorities around the world to secure sound and informed decision-making.

Depending on your experience and/or interest, tasks will include:

• Writing, compiling, and reviewing regulatory CMC submissions in accordance with internal requirements and external regulatory guidelines and regulation.
• Planning, coordinating, and executing life cycle management activities while supporting subject matter experts delivering source documents related to regulatory activities.
• Supporting regulatory inspections and compliance, and internal/external audits and inspections.
• Commenting and approving validation and stability documentation.
• Execute maintenance of internal and external regulatory procedures.
• Support alignment of cross functional procedures.