Regulatory Affairs Strategist

4 weeks ago

Copenhagen, Copenhagen, Denmark Voisin Consulting SARL Full time

**About the Role**

We are seeking a seasoned Senior Regulatory Scientist to spearhead our regulatory affairs efforts in the Nordic region. This is an excellent opportunity for individuals who thrive in dynamic environments and are passionate about driving innovation in Life Science.

**Responsibilities:**

  • Develop and execute regulatory strategies for assigned projects, ensuring timely submission of regulatory filings.
  • Lead interactions with regulatory agencies to obtain 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.

**Requirements:**

  • 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.

**Compensation:** We offer a competitive salary range of **€80,000 - €110,000** per annum, commensurate with experience.

**Location:** The role is based in the Nordic region, with opportunities for remote work.

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