Regulatory Affairs Specialist

We are seeking a proactive and experienced Regulatory Affairs Development Specialist to bring expertise, structure, and a strong skillset to our growing team at 2care4 Generics.

About the Role

• 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 will 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.

Requirements

• 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 humor that brightens the workplace.
• Relationship Builder: Strong communication skills, even in remote settings.
• Language Skills: Proficiency in spoken and written English, and ideally Danish.

Working Conditions

Our offices are based in Esbjerg (HQ) and Odense (Satellite office), with flexible work-from-home options tailored to individual needs. We estimate the salary for this position to be around 100,000 DKK per year, depending on experience.