Open Positions: Associate Director, Regulatory Affairs
Arvinas is a clinical-stage biopharmaceutical company focused on developing new small molecules ‒ known as PROTAC® (PROteolysis Targeting Chimera) protein degraders ‒ aimed at degrading disease-causing cellular proteins via proteolysis. Based on innovative research conducted at Yale University by Dr. Craig Crews, Founder and Chief Scientific Advisor, the company is translating natural protein degradation approaches into novel drugs for the treatment of cancer and other diseases. Our proprietary PROTAC®-based drug paradigm induces protein degradation, rather than protein inhibition, using the ubiquitin proteasome system and offers the advantage of potentially targeting “undruggable” as well as “druggable” elements of the proteome. This greatly expands the ability to create drugs for many new, previously unapproachable targets. For more information, visit www.arvinas.com.
This exciting new role at Arvinas will be focused on the identification of optimal product development strategy, filing of high-quality regulatory submissions, maintenance of regulatory dossiers, and coordinating the interaction with regulatory agencies in relation to submissions and other relevant topics. This role is perfect for a multi-tasker who is at their best in a dynamic and diverse, cross-functional working environment.
This position reports in through our Regulatory Affairs function and will be located at our headquarters in New Haven, CT.
Key responsibilities of this role include, but are not limited to:
• Collaborate with drug development program team members to plan and prepare high-quality regulatory submissions.
• Track and review documents as they are prepared for submission to health authorities; write and contribute content as needed.
• Coordinate interaction with regulatory agencies. Lead clinical and non-clinical agency correspondence and regulatory applications (IND and CTA, as needed) to support clinical development activities.
• Identify optimal product development strategy.
• Serve as regulatory representative on cross-functional teams.
• Make regulatory decisions with regard to submission acceptability.
• Review technical documents for relevant compliance adherence, and identification of data gaps/needs.
• Effectively communicate with individuals at all levels of the organization.
• Offer training/coaching regarding compliance.
• Develop quality standards for regulatory affairs.
• Successful track record of preparing and filing relevant regulatory documentation required.
• Must have thorough understanding of the relevant regulations and guidelines.
• Must be detail-oriented with ability to effectively organize and prioritize tasks to achieve established deadlines.
• Demonstration of excellent written, oral, and interpersonal communication skills is required.
• Must be proficient in Microsoft Office applications, especially Word.
• Experience in oncology/neuroscience is preferred.
- Bachelor’s degree in a scientific discipline, with a minimum of 10 years of applicable and relevant experience, or Master’s degree in a scientific discipline with a 5-years of applicable and relevant experience
Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness, and financial security of our employees and their families. Benefits include group medical, vision, and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com.
Arvinas is an Equal Opportunity Employer.