Regulatory Affairs Specialist

1 month ago


Copenhagen, Copenhagen, Denmark VCLS Full time
Senior Regulatory Scientist

We are seeking an experienced Senior Regulatory Scientist to join our team at VCLS. As a trusted advisor, you will work closely with clients to develop and implement regulatory strategies that drive business success.

Key Responsibilities:

  • Develop and execute regulatory plans for client projects, ensuring alignment with technical requirements and business objectives.
  • Provide strategic guidance on regulatory pathways, risks, and opportunities to help clients navigate complex regulations.
  • Lead client interactions with regulatory agencies to secure timely approvals for clinical trials, marketing applications, and post-marketing activities.
  • 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.

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.

At VCLS, we are committed to delivering exceptional results for our clients. If you are a motivated and experienced Senior Regulatory Scientist looking for a new challenge, we would love to hear from you.



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