Lead Regulatory Affairs Scientist

7 days ago


Copenhagen, Copenhagen, Denmark VCLS Full time

Senior Regulatory Scientist

As we expand our operations, we are looking to recruit experienced Senior Regulatory Scientists. This position is ideal for individuals who thrive in a dynamic environment and are eager to collaborate with leading clients in the Life Sciences sector, while also pursuing continuous personal and professional growth.

Key Responsibilities:

  • Formulate and implement regulatory strategies for designated projects, including the preparation and submission of necessary regulatory documents.
  • Oversee communications with regulatory bodies to secure prompt approvals for clinical trials, marketing submissions, and post-marketing initiatives.
  • Analyze and interpret applicable regulations and guidance materials to ensure adherence to regulatory standards.
  • Act as the regulatory expert within various product development teams, offering insights on FDA and EMA regulations, policies, and guidance.
  • Guide and support junior members of the regulatory affairs team.
  • Represent the organization in engagements with external parties, including industry associations, regulatory bodies, and clients.

Qualifications:

  • Advanced degree in life sciences or a related discipline.
  • A minimum of 3 years of experience in regulatory affairs within the biotechnology or pharmaceutical sectors.
  • Proven experience with regulatory submissions and interactions with regulatory authorities.
  • Familiarity with US and EU regulatory frameworks for biologics and small molecules.
  • Strong grasp of clinical development processes and requirements for clinical trials.
  • Exceptional written and verbal communication abilities.
  • Capability to collaborate effectively within a team and across various functions.
  • Robust strategic and analytical thinking skills.

If you are dedicated to advancing Regulatory Science and are motivated to foster innovation within the life sciences field, we encourage you to consider this opportunity at VCLS, where you can play a vital role in the development of transformative products that positively impact patient outcomes.



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