Senior Regulatory Affairs Development Specialist

Are you ready to help shape the future of our Development team? We’re looking for a proactive and experienced Senior RA Development Specialist to bring expertise, structure, and a strong skillset to our growing team. At 2care4 Generics, you’ll enjoy an open-minded workplace with plenty of room for new ideas and a positive atmosphere.

About 2care4 Group
Since its foundation in 2005, the 2care4 Group has rapidly expanded in the fields of parallel import and generic pharmaceuticals. Today, we employ around 380 people across Europe, driven by a commitment to growth and quality.

Why 2care4 Generics?
2care4 Generics, part of the 2care4 Group, is a young, fast-growing organization with bold ambitions. Here, you’ll have the chance to make a meaningful impact as we build our pipeline and portfolio of generic products across the Nordics.

What You’ll Do:

• Evaluate New Products: Assess new product opportunities for our pipeline, from a regulatory perspective.
• Drive Product Development: Collaborate with external partners on new development projects.
• Prepare Regulatory Documentation: Support regulatory filings with essential documentation.
• Develop and Streamline Processes: Develop and refine systems, SOPs and procedures to support products across our organization.
• Share Expertise: Provide colleagues with detailed RA information and support.
• Communicate Globally: Liaise with regulatory authorities and development partners on an international basis.
• Authority Communication: Manage end-to-end communication with regulatory authorities throughout the MAA process.
• Application Documentation: Prepare MAA responses and update dossier documentation in collaboration with internal and external partners.

In this role, you’ll have significant freedom to shape your work. If you identify solutions that drive progress, you can count on us to act quickly and decisively to put them into practice.

What We’re Looking For:

• Regulatory Expertise: Experience in pharmaceutical regulatory affairs, ideally within generics and with understanding of the Nordic regulatory landscape.
• Self-Motivation: Comfortable with independent work and a collaborative team environment
• Detail-Oriented: Committed to quality and take pride and responsibility in your daily work
• Adaptability: Eager to take on new challenges alongside your routine tasks
• Positive Mindset: A friendly attitude and sense of humour that brightens the workplace.
• Relationship Builder: Strong communication skills, even in remote settings.
• Language Skills: Proficiency in spoken and written English, and ideally Danish.

Location and Flexibility
Our offices are based in Esbjerg (HQ) and Odense (Satellite office), with flexible work-from-home options tailored to individual needs.

Join us to build a career where your insights and initiative will make an immediate impact!

For further information about the position, please contact Head of Development, Jonathan David Castile on tel.: +45 2780 4709 or email: [email protected] .

You apply electronically by clicking on the link. Please attach your application as well as your CV and documentation for relevant employment. Employment interviews are held on an ongoing basis and employment will take place when the right candidate has been found. Start date will be as soon as possible.