Regulatory Affairs Specialist

3 days ago

Copenhagen, Copenhagen, Denmark VCLS Full time
Senior Regulatory Scientist (Consultant)

We are expanding our business and seeking experienced Senior Regulatory Scientists who are passionate about the evolving Life Sciences industry and excited by the opportunity to work with cutting-edge clients. This consulting role is ideal for individuals who not only bring deep regulatory expertise but also have the soft skills and commercial acumen to provide strategic advice and build strong client relationships.

Key Responsibilities:

  • Develop and implement regulatory strategies for a diverse portfolio of client projects, ensuring alignment with both technical requirements and business objectives.
  • Act as a trusted consultant, advising clients on regulatory pathways, risks, and opportunities to help them navigate complex regulations and achieve commercial success.
  • Lead client interactions with regulatory agencies to secure timely approvals for clinical trials, marketing applications, and post-marketing activities.
  • Provide strategic support for Life Cycle Management (LCM), ensuring ongoing compliance and facilitating product evolution to meet market needs.
  • Evaluate and interpret regulatory requirements, providing clear, actionable guidance tailored to each client's unique situation.
  • Serve as a regulatory subject matter expert on cross-functional teams, blending technical insights with strategic business considerations.
  • Mentor and support junior regulatory team members, fostering a client-centric, solutions-driven approach across the team.
  • Represent 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.

If you are ready to leverage your regulatory expertise in a consulting role, partnering with some of the most innovative clients in Life Sciences, we would love to hear from you. At VCLS, we are committed to shaping the future of healthcare while advancing your own career in a collaborative, dynamic environment.

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