Senior Regulatory Scientist

Senior Regulatory Scientist

We are continuing to invest in growing our business and are now seeking to hire Senior Regulatory Scientists. This role will speak to those who are excited at the pace of change and innovation in Life Science, who want have an appetite to partner the most cutting edge clients and those who want to continuously learn, develop and progress 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.
• 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.

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. Join our team at VCLS and contribute to the development of ground breaking products that will make a difference in patients' lives.