Global Regulatory Affairs Professional to AJ Vaccines
We save lives worldwide. Will you join us?
We are looking for two Global Regulatory Affairs Professionals preferably with solid regulatory knowledge and experience with life-cycle management (LCM) activities for biological products.
Vaccines are our specialty
AJ Vaccines A/S is an international company with Danish roots. Perhaps you have not heard of us yet, and with good reason. We are in fact a new international pharmaceutical company that has taken over the vaccine production facilities of Statens Serum Institute in January 2017. We are in front of an exciting future where we develop and expand the existing production, invest in our facilities and produce more vaccines. The change process is massive and offers a fantastic and unique opportunity to be instrumental in the transformation and turn-around. Our goal is to establish a scaled-up production and a competitive private company from our central location at Artillerivej in Copenhagen.
Vaccines are our specialty and we are proud of our products that save lives worldwide. We hope to have you as part of our dedicated team.
Regulatory Affairs responsibilities and ambitions
Regulatory Affairs, which is part of the Regulatory & Medical Affairs department, is responsible for global regulatory activities throughout the life cycle of our products, in 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 minimise time to market while ensuring compliance in a continuously changing global regulatory environment.
You will get the opportunity to work in a team of 15 highly competent and dedicated colleagues who have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders.
As Global Regulatory Affairs Professional at AJ Vaccines A/S, you will be working with 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. You will provide competitive access to the global marketplace by ensuring optimal scientific documentation for the licensing of our products.
Your main tasks will include:
- Planning, coordinating and executing the regulatory tasks associated with LCM activities of existing products.
- Writing, compiling and reviewing technically complex 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 while meeting prescribed submission timelines.
- Participating in the development and implementation of regulatory strategies and providing regulatory support to stakeholders.
- Reviewing change controls to support post-approval changes. Ensuring information in the change control is accurate and scientifically sound and implementation of the change in a regulatory timely and effective manner.
Who are you?
You have a relevant Master of Science degree and at least three years of experience in Regulatory Affairs, preferably within Biologics.
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. 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 regulatory requirements within LCM activities in the EU and preferably also in major markets outside the EU,
- the ability to never lose sight of the bigger picture, when focusing on even the smallest details,
- clear focus on agreed objectives, even when working with tight deadlines and
- a positive approach to life, good humour and great communication skills.
An exciting position with a great level of variability and the possibility to affect your own tasks, internal procedures and the 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 fantastic team spirit.
Do you want to know more?
For further information about the position, please contact Head of Regulatory Affairs Section, Lone Dyrby at +45 41714751 or Global Regulatory Affairs Specialist, Trine Junker Bundgaard Larsen at +45 7229 7386.
Are you interested?
Your application and CV in English should be submitted as soon as possible, as we will be reviewing incoming applications continuously.