Vice President of Regulatory Affairs

Luminary Group is seeking a highly skilled and experienced Vice President of Regulatory Affairs to join our client. As the Vice President of Regulatory Affairs, you will play a critical role in the development and implementation of regulatory strategies to support our client's products in the pharmaceutical, biotechnology, and medical device industries.

Responsibilities:

• Lead the regulatory affairs function and provide strategic guidance to ensure compliance with global regulatory requirements.
• Develop and execute regulatory strategies for product development, registration, and post-approval activities, ensuring timely and successful regulatory submissions.
• Interact with regulatory authorities and participate in meetings and negotiations to address regulatory issues and ensure alignment with company objectives.
• Monitor and interpret changing regulatory trends and requirements, and provide guidance on potential impact to the organization.
• Collaborate with cross-functional teams to review and prepare regulatory submissions, including INDs, NDAs, BLAs, and marketing applications.
• Oversee the preparation of regulatory documents, including briefing packages, responses to regulatory inquiries, and labeling changes.
• Ensure compliance with regulatory reporting requirements and timelines.
• Manage and mentor a team of regulatory professionals, providing guidance, training, and performance evaluations.
• Stay up-to-date with global regulatory guidelines and requirements, and guide the organization in implementing best practices and industry standards.
• Collaborate with internal stakeholders to provide regulatory guidance and support for business development activities, including due diligence assessments and regulatory integration of acquired products.

Requirements

• Bachelor's degree in a scientific or related field; advanced degree (PhD, PharmD) preferred.
• Minimum of 10 years of experience in regulatory affairs in the pharmaceutical, biotechnology, or medical device industries.
• Demonstrated experience in developing and executing regulatory strategies for global product development, registration, and post-approval activities.
• Extensive knowledge of global regulatory requirements, including FDA, EMA, and ICH guidelines.
• Proven track record of successful interactions with regulatory authorities.
• Strong leadership and management skills, with the ability to effectively lead and develop a team.
• Excellent verbal and written communication skills, with the ability to clearly and convincingly present regulatory strategies and perspectives.
• Strong organizational and project management skills, with the ability to prioritize and manage multiple competing tasks.
• Experience working in a cross-functional team environment, collaborating with R&D, clinical, quality, and commercial teams.
• Knowledge of advanced therapy medicinal products (ATMPs) and/or orphan drug regulations is a plus.