Vice President, Regulatory Affairs – USA remote

Global Life Science hub has partnered with a rapidly growing biopharmaceutical company that is involved in developing novel drug products across a range of therapeutic areas such as Oncology, CNS, and Rare Diseases. The company has an innovative pipeline and has established strategic partnerships with leading biopharmaceutical companies.

We are seeking a new Vice President of Regulatory Affairs to provide strategic leadership and oversee the regulatory affairs function. The successful candidate will be responsible for developing and implementing regulatory strategies to support the development and approval of new products, ensuring compliance with global regulatory requirements and guidelines, and leading interactions with regulatory authorities, including the FDA and EMA.

As the Vice President of Regulatory Affairs, you will collaborate with cross-functional teams to ensure timely submission of high-quality regulatory filings, provide guidance and mentorship to the regulatory affairs team, and stay abreast of evolving regulatory requirements and industry trends. You will also represent the company at industry conferences and regulatory meetings, participate in due diligence activities for potential business development opportunities, and contribute to the development and implementation of company-wide policies and procedures related to regulatory affairs.

Requirements:

• Minimum of 10 years of experience in regulatory affairs in the biopharmaceutical industry
• Proven track record of success in regulatory affairs and drug development, including successful NDA/BLA submissions and approvals.
• Strong knowledge of global regulatory requirements and guidelines
• Experience leading regulatory affairs teams in a global setting
• Excellent written and verbal communication skills

Responsibilities:

• Provide strategic leadership and oversight of the regulatory affairs function.
• Develop and implement regulatory strategies to support the development and approval of new products.
• Ensure compliance with global regulatory requirements and guidelines.
• Collaborate with cross-functional teams to ensure timely submission of high-quality regulatory filings.
• Lead interactions with regulatory authorities, including the FDA and EMA
• Provide guidance and mentorship to the regulatory affairs team.
• Stay abreast of evolving regulatory requirements and industry trends.
• Represent the company at industry conferences and regulatory meetings.
• Participate in due diligence activities for potential business development opportunities.
• Contribute to the development and implementation of company-wide policies and procedures related to regulatory affairs.

If this job doesn’t quite interest you, we may have other opportunities that are more relevant.

So please visit our website – www.glshub.com or reach out via:

Tel – +44 (0) 204 599 8130