We Save Lives Worldwide; Would You Like to Join Us? 
We are looking for a professional or 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 scientist in 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 regulations. This requires extensive interaction with stakeholders within AJ Vaccines A/S, as well as with external partners associated to the specific market
• 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

Who are You?   
You have a master’s degree in pharmacy, biological /chemical sciences, biomedical/mechanical engineering, or another related subject, preferred with minimum of 3 years of regulatory affairs experience or other relevant experience from the pharmaceutical industry.

You will have a great diversity of tasks in a regulatory context, which requires problem-solving, independence, understanding of complexity, creativity, and collaborative skills. You must be systematic and structured in your approach and with an analytical sense, detail-oriented and understand stakeholder and business demands with a positive mindset and constructive attitude. You are a passionate and proactive team player, who thrives on working independently in a dynamic matrix organization in an international environment.

Additionally, the successful candidate has:  

• Knowledge of current regulatory and CMC guidelines, preferably within biologicals for human use
• Confident in coordination and planning task in close collaboration with stakeholders
• Ability to manage several tasks in parallel
• Good communications and collaborative skills cross functional and cross competencies
• Skills and interest in IT-systems and knowledge of eCTD

We Offer  
An exciting position with a great level of variability and the possibility to affect your tasks, internal procedures, and future activities in Regulatory Affairs at AJ Vaccines A/S. You will be an integral part of a competent and committed team with high professionalism and a fantastic team spirit.

Do You Want to Know More?   
For further information about the position, please contact the Director of Regulatory Affairs, Hans-Henrik Kristensen at +45 2920 3336.

Are You Interested?   
Your CV in English should be submitted as soon as possible, as we will be reviewing incoming applications continuously.

At AJ Vaccines, we are committed to an inclusive recruitment process, ensuring equal opportunities for all applicants. Consequently, we kindly request that you refrain from including a photo in your CV.

We look forward to hearing from you!