Life Science People
Life Science People United States United States
1 month ago
Director of Regulatory Affairs
We are looking for an experienced Director of Regulatory Affairs to join our client. As the Director of Regulatory Affairs, you will be responsible for providing strategic leadership in regulatory affairs, ensuring that all regulatory requirements and guidelines are met, and collaborating with cross-functional teams to achieve company goals. The ideal candidate should have experience in developing and executing regulatory strategies, managing IND, BLA, NDA, and FDA conversations, and have a strong knowledge of the regulatory landscape in the pharmaceutical industry.
• Develop and implement regulatory strategies to support product development and commercialization goals.
• Provide guidance and leadership to the regulatory team, ensuring that all team members are aligned with the company's regulatory strategy.
• Manage regulatory submissions, including IND, BLA, NDA, and other related filings.
• Participate in FDA meetings, including pre-IND, pre-BLA, pre-NDA, and other relevant meetings.
• Ensure compliance with all applicable regulations, guidelines, and laws.
• Collaborate with cross-functional teams to achieve company goals.
• Review and provide regulatory guidance on clinical and nonclinical study designs, protocols, and reports.
• Stay up-to-date with the latest developments in regulatory affairs, particularly in RNA-related regulatory topics.
• Build and maintain strong relationships with key regulatory agencies and other external stakeholders.
• Develop and maintain a network of regulatory experts and consultants to support the company's regulatory strategy.
• Serve as the primary contact for regulatory agencies and communicate with them on regulatory matters.
• Bachelor's degree in a related field, with a Master's or PhD preferred.
• At least 8 years of experience in regulatory affairs in the pharmaceutical industry.
• Strong knowledge of IND, BLA, NDA, and other regulatory submissions.
• Experience in regulatory strategy development and execution.
• Excellent communication and leadership skills.
• Experience with RNA-related regulatory topics is a plus.
Due to the industry specific nature of this role, candidates without experience in the biotech/pharma industry will not be considered
Jobs in United States United States
Director of Regulatory Affairs United States jobs
Copyright © 2023 Fonolive. All rights reserved.