Regulatory Affairs Expert

2 weeks ago

Copenhagen, Copenhagen, Denmark Voisin Consulting SARL Full time
Senior Regulatory Scientist Role

We are continuing to grow our Nordic business and are now seeking a Senior Regulatory Scientist. This role is suitable for those who are excited at the pace of change and innovation in Life Science, who want to partner with cutting-edge clients and continuously learn, develop, and progress personally and professionally.

Key Responsibilities:

  • Develop and execute regulatory strategies for assigned projects, including the preparation and submission of regulatory filings.
  • Lead interactions with regulatory agencies to obtain timely approvals for clinical trials, marketing applications, and post-marketing activities.
  • Evaluate and interpret relevant regulations and guidance documents to ensure regulatory compliance.
  • Serve as the regulatory subject matter expert on various product development teams, providing guidance on FDA and EMA regulations, policies, and guidance documents.
  • Manage and mentor junior regulatory affairs team members.
  • Represent the company in discussions with external stakeholders, including industry groups, regulatory agencies, and customers.
  • Advanced degree in life sciences or a related field.
  • Minimum of 3 years of experience in regulatory affairs in the biotechnology or pharmaceutical industry.
  • Experience of regulatory submissions and interactions with regulatory agencies.
  • Knowledge of US and EU regulatory requirements for biologics and small molecules.
  • Strong understanding of clinical development processes and clinical trial requirements.
  • Excellent written and verbal communication skills.
  • Ability to work collaboratively within a team and across functions.
  • Strong strategic and analytical thinking skills.

If you are passionate about Regulatory Science and have a desire to drive innovation in the life sciences industry, we would love to hear from you. At Voisin Consulting SARL, we contribute to the development of groundbreaking products that make a difference in patients' lives.

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