Do you have 5+ years of Regulatory Affairs experience within Biotech/Pharma? Have you been involved in FDA interactions?
Invenia Group has partnered with one of the world’s leading AI Drug Discovery companies accelerating drug discovery and development by leveraging their rapidly evolving, proprietary platform. The company is now looking to hire an (Snr) Director of Regulatory Affairs, to build their regulatory team in Boston.
As the Senior Director of Regulatory Affairs, you will play a crucial role in leading and managing all regulatory activities to ensure compliance with relevant regulations and guidelines. You will collaborate closely with cross-functional teams to develop and execute regulatory strategies, drive successful submissions, and support the development and commercialization of our innovative drug candidates.
Responsibilities:
- Develop and implement regulatory strategies to support the development, registration, and commercialization of their therapeutic assets.
- Lead and manage all regulatory affairs activities, including regulatory submissions, compliance, and interactions with regulatory authorities.
- Collaborate with cross-functional teams, including R&D, clinical development, quality assurance, and commercial teams, to provide regulatory guidance and support throughout the product lifecycle.
- Prepare, review, and submit high-quality regulatory submissions, including INDs, NDAs, BLAs, and other relevant documents, ensuring adherence to regulatory requirements and timelines.
- Represent the company in interactions and negotiations with regulatory agencies, including FDA and other global regulatory bodies.
- Oversee regulatory activities for clinical trials, ensuring compliance with applicable regulations and guidelines.
- Establish and maintain effective relationships with regulatory agencies, ensuring open communication and prompt resolution of regulatory issues.
- Provide strategic regulatory guidance and insights to senior leadership and contribute to business development activities, including due diligence for potential partnerships and acquisitions.
Requirements:
- An advanced degree in a scientific or healthcare-related field is preferred.
- 10+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, including significant experience in drug development and submissions.
- Deep understanding of US and global regulatory requirements and guidelines, with hands-on experience in regulatory submissions and interactions.
- Experience in AI-based drug discovery or digital health technologies is highly desirable.
- Proven track record of successful regulatory submissions and approvals.
- Strong leadership and managerial skills, with the ability to effectively lead and mentor a team.
- Excellent communication and interpersonal skills, with the ability to collaborate and influence stakeholders at all levels.
- Strong strategic thinking and problem-solving abilities, with a focus on innovative and agile approaches to regulatory affairs.
Sound interesting? This is a fantastic opportunity to join an organization committed to fostering better cultural competency, equity, and diversity. To find out more information regarding this role, please apply.
