Global Regulatory Affairs CMC specialist

We are looking for candidates with broad experience within Regulatory Affairs LCM of biologics.

We are saving lives worldwide

. Would you like to join?

Global Regulatory Affairs are opening positions to support expanding activities in Life Cycle Management (LCM) of existing products. AJ Vaccines invites candidates with broad experience within Regulatory Affairs LCM of biologics, worldwide.

The responsibilities and ambitions of the team

Regulatory Affairs, CMC is responsible for global regulatory activities throughout the life cycle of our products in more than 50 countries. We work closely together with our colleagues across functions and with our partners and consultants worldwide. We strive to be responsive to the 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 be part of a highly competent team with dedicated colleagues, who have a unique combination of scientific insight, regulatory understanding and the ability to navigate many agendas and stakeholders.

Your work tasks

As a specialist in Global Regulatory Affairs at AJ Vaccines A/S, you will be managing LCM activities for our biological products. You will drive the regulatory interactions concerning scientific issues with colleagues in multiple functions, partners, and regulatory authorities around the world to secure sound and informed decision-making.

With your broad experience it is expected that:

• You will plan, coordinate, and execute the regulatory tasks associated with LCM activities of existing products
• You will write, compile and review 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
• You will maintain administrative obligations with all Authorities
• You will participate in the development and implementation of regulatory strategies and provide regulatory support to internal stakeholders

You will review 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 hold a relevant MSc. degree and have several years of experience in Regulatory Affairs, preferably within Biologics
• You are capable of combining your scientific knowledge with the understanding and interpretation of regulatory expectations from multiple authorities in order to solve a great diversity of tasks in a regulatory context
• You have a systematic and structured way of working, which gives you the capacity to orchestrate multiple submissions under several authorities in parallel
• You are detail-oriented and understand stakeholder and business demands

Regulatory Affairs, CMC in AJ Vaccines A/S has a key role across all functions. To assure alignment between functions your interpersonal skills will be challenged on a daily basis.

In addition, we expect:

• You are up to date on common Microsoft tools
• You are a passionate and proactive team player, who thrive on working independently in a dynamic matrix organization in an international environment
• You have knowledge of regulatory requirements within LCM activities in the EU and in major markets outside the EU e.g. Middle East and Asia
• You have the ability to never lose sight of the bigger picture, when focusing on even the smallest details
• You have clear focus on agreed objectives, even when working with tight deadlines, a positive approach to life, good humor, and great communication skills

We offer

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.

Would you like to know more?

For further information about the position, please contact Director of Regulatory Affairs, Janne Rahbek at +45 7229 7910.

If you recognize yourself in the role of Global Regulatory Affairs CMC specialist at AJ Vaccines A/S, please send your application and CV in English as soon as possible, as we will be reviewing incoming applications continuously.

We will be conducting interviews on an ongoing basis. They will be conducted virtually and further on you will be invited for a walk with one or two of your new colleagues.