Regulatory Affairs Specialist

3 weeks ago


Copenhagen, Copenhagen, Denmark VCLS Full time

Regulatory Affairs Specialist



We are seeking an experienced Regulatory Affairs Specialist to join our team at VCLS. As a key member of our regulatory team, you will play a critical role in ensuring that our clients' products meet the latest regulatory requirements.



Your primary responsibilities will include:




  • Developing and implementing regulatory strategies for client projects, ensuring alignment with both technical requirements and business objectives.
  • Acting as a trusted advisor, providing clients with expert guidance on regulatory pathways, risks, and opportunities to help them navigate complex regulations.
  • Leading client interactions with regulatory agencies to secure timely approvals for clinical trials, marketing applications, and post-marketing activities.
  • Providing strategic support for Life Cycle Management (LCM), ensuring ongoing compliance and facilitating product evolution to meet market needs.
  • Evaluating and interpreting regulatory requirements, providing clear, actionable guidance tailored to each client's unique situation.
  • Serving as a regulatory subject matter expert on cross-functional teams, blending technical insights with strategic business considerations.
  • Mentoring and supporting junior regulatory team members, fostering a client-centric, solutions-driven approach across the team.
  • Representing the company and clients in discussions with external stakeholders, including regulatory agencies, industry groups, and customers.


Requirements




  • Advanced degree in life sciences or a related field.
  • Minimum of 3 years of experience in regulatory affairs within the biotechnology, pharmaceutical, or CRO industry.
  • Proven experience in client-facing roles, with the ability to manage multiple stakeholders and provide consultative, solution-oriented advice.
  • Strong knowledge of US and EU regulatory requirements for biologics and small molecules, along with expertise in Life Cycle Management (LCM) activities.
  • Excellent communication and interpersonal skills, with the ability to translate complex regulatory language into business-focused advice for clients.
  • Demonstrated ability to integrate regulatory strategies with broader commercial goals, balancing scientific rigor with business priorities.
  • Strong leadership and mentorship abilities, with a commitment to developing talent within the regulatory team.
  • Ability to work effectively in a consulting environment, managing multiple projects and delivering results in a fast-paced, client-focused setting.


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