Senior Regulatory Scientist

Senior Regulatory Scientist

VCLS - Voisin Consulting Life Sciences

Copenhagen, Cambridge or Boulogne-Billancourt

We are continuing to invest in growing our business and are now seeking to hire Senior Regulatory Scientists. This role will appeal to those who are excited by the pace of change and innovation in the Life Sciences, have a passion for partnering with cutting-edge clients, and possess a strong desire to continuously learn, develop, and progress both personally and professionally.

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;
• Oversee Life Cycle Management (LCM) activities, ensuring ongoing regulatory compliance for approved products, including managing variations, renewals, and post-marketing commitments;
• Provide regulatory guidance and support throughout the product lifecycle, from development to post-approval, ensuring alignment with evolving regulatory landscapes;
• 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

Qualifications:

• Advanced degree in life sciences or a related field;
• Minimum of 3 years of experience in regulatory affairs within the biotechnology or pharmaceutical industry;
• Experience with 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, clinical trial requirements, and Life Cycle Management (LCM) activities;
• Excellent written and verbal communication skills;
• Ability to work collaboratively within a team and across functions;
• Strong strategic and analytical thinking skills.

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