Associate Directory/Director of Regulatory Affairs

Arvinas Inc, New Haven, CT

The remit of this role will include 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 diverse, cross-functional working environment.

Responsibilities

  • Tracking and review of documents, as they are prepared for submission to health authorities
  • Work with regulatory operations specialists to prepare and file high-quality submissions for regulatory authorities.
  • Identify optimal product development strategy
  • 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.
  • Serve as regulatory representative on cross-functional teams
  • Make regulatory decisions in 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
  • All ad-hoc duties as assigned

Skills and Qualifications

  • BA in a scientific discipline, with a minimum of 10 years of applicable and relevant experience, or MA in a scientific discipline with a 5-years of applicable and relevant experience
  • Successful track record of preparing and filing relevant regulatory documentation
  • Thorough understanding of the relevant regulations and guidelines
  • Ability to effectively organize and prioritize tasks to achieve established deadlines
  • Excellent written, verbal, and interpersonal communication skills
  • Experience in oncology/rare diseases preferred

Location

New Haven, CT

Please send CV and cover letter to: careers@arvinas.com.