Senior Manager or Associate Director Regulatory Affairs
My client is seeking a Senior Manager or Associate Director of Regulatory Affairs to hit the ground running in support of their diverse and rapidly growing pipeline. In this newly created role you will manage the regulatory aspects of projects and products, including the preparation and submissions of all sections of INDs/CTAs. This company offers you the ability to grow your career with a mid-stage development pipeline in three different therapeutic categories. The ideal candidate is a seasoned, experienced regulatory leader who has proven success with regulatory strategy and submissions.
Responsibilities:
- Manage the preparation of submissions of INDs and CTAs, amendments, and meeting applications to regulatory agencies including the FDA, Health Canada, and the EMA
- Represent Regulatory Affairs at clinical project team meetings
- Communicate regulatory information and work with cross-functional multidisciplinary study teams on preparation of internal documents that are in compliance with regulatory guidance
- Support the Senior Director with the management, planning and preparation of BLAs/MAAs
- Lead the preparation of IND Annual Reports/DSURs and ensure timely safety reporting to regulatory agencies
- Maintain archive and tracking of ongoing INDs/CTAs submissions, FDA/Health Authority communication and related issues to resolution
- Work directly with external vendor(s) in support of e-ctd submissions
Knowledge and Skills:
- Minimum BS in a scientific discipline required, advanced degree preferred
- Minimum 5-8 years of regulatory experience with 8+ years’ industry experience
- Must have knowledge of eCTD and filing of INDs
- Experience filing BLAs, NDAs or MAAs a plus but not a requirement
- Experience filing and maintaining CTAs in Canada and Europe preferred
- Knowledge of GCPs as well as European Clinical Trials Directive
- Must have the ability to work in a collaborative, science driven environment