Senior Regulatory Affairs Specialist
1 week ago
We are committed to investing in our Nordic business and are seeking a Senior Regulatory Scientist to join our team. This role will appeal to those who are passionate about the pace of change and innovation in Life Science, who want to partner with cutting-edge clients, and who want to 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 are committed to developing groundbreaking products that will make a difference in patients' lives.
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