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.
- 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
New Haven, CT
Please send CV and cover letter to: firstname.lastname@example.org.