Regulatory Affairs Specialist for Pipeline Development

1 day ago


Esbjerg, Esbjerg Kommune, Denmark Poulsen Job & Research ApS Full time

We're seeking a seasoned Regulatory Affairs expert to drive our pipeline development forward. As a Senior RA Development Specialist, you'll be responsible for evaluating new products, collaborating with external partners, and preparing regulatory documentation.

About the Role
  • Evaluate New Products: Assess new product opportunities 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 internationally.

In this role, you'll have the freedom to shape your work and contribute to our growing team. If you identify solutions that drive progress, you can count on us to act quickly and decisively.

About Us

At 2care4 Generics, we're a young, fast-growing organization with bold ambitions. We're committed to growth and quality, employing around 380 people across Europe. Our offices are based in Esbjerg (HQ) and Odense (Satellite office), with flexible work-from-home options tailored to individual needs.

Requirements
  • Regulatory Expertise: Experience in pharmaceutical regulatory affairs, ideally within generics, and 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 daily work.
  • Adaptability: Eager to take on new challenges alongside 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.
What We Offer

A competitive salary of approximately €60,000 - €80,000 per year, depending on experience, plus benefits and opportunities for career growth in a dynamic and supportive environment.



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