Regulatory Affairs Expert

We are seeking a proactive and experienced Senior RA Development Specialist to bring expertise, structure, and a strong skillset to our growing team at Poulsen Job & Research ApS. At 2care4 Generics, you'll enjoy an open-minded workplace with plenty of room for new ideas and a positive atmosphere.

• 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.

• 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.