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Senior Regulatory Scientist
4 months ago
Senior Regulatory Scientist
We are looking to expand our Nordic business and are in search of Senior Regulatory Scientists. This position is ideal for those who thrive in a fast-paced environment and are passionate about the advancements and evolution in Life Science. We are seeking individuals who are eager to collaborate with top-tier clients and are committed to continuous personal and professional growth.
Responsibilities:
- Develop and implement regulatory strategies for projects, including preparing and submitting regulatory filings.
- Lead communications with regulatory agencies to secure timely approvals for clinical trials, marketing applications, and post-marketing activities.
- Evaluate and interpret applicable regulations and guidance to ensure regulatory adherence.
- Act as the regulatory expert on product development teams, offering insights on FDA and EMA regulations.
- Supervise and guide junior regulatory affairs team members.
- Participate in discussions with external stakeholders such as industry groups, regulatory bodies, and clients.
Requirements
- Advanced degree in life sciences or related field.
- Minimum of 3 years experience in regulatory affairs within biotechnology or pharmaceuticals.
- Proven track record in regulatory submissions and engagements with regulatory agencies.
- Familiarity with US and EU regulatory standards for biologics and small molecules.
- In-depth understanding of clinical development processes and trial requirements.
- Strong written and verbal communication abilities.
- Effective collaboration skills within and across teams.
- Excellent strategic and analytical thinking capabilities.
If you are dedicated to Regulatory Science and are keen on fostering innovation in the life sciences sector, we are eager to connect with you. Be part of our team at VCLS and contribute to the creation of groundbreaking products that have a positive impact on patients' lives.