Regulatory Affairs Project Leader
My client is seeking a Regulatory Affairs Project Leader to hit the ground running in support of their diverse and rapidly growing pipeline. You will lead the preparation of IND and CTA submissions for rare orphan programs for the US, Canada, EMA and local European countries. This company offers you the ability to grow your career within stable, friendly, and collaborative environment while helping to advance programs across three different therapeutic categories. The ideal candidate is a leader who is ready to jump right in and contribute!
Responsibilities:
- Evaluate the requirements and lead the preparation of IND and CTA submissions for initial applications, updates, or correspondence in US, Canada, and Europe.
- Communicate regulatory information to and work with cross-functional multidisciplinary study teams on preparation of internal documents that are in compliance with regulatory submissions
- Maintain and submit documents as needed for orphan designation and for other expedited programs as applicable
- Participate in CMC change control to ensure released products are manufactured in agreement with established regulatory submissions, as well as preparation of CMC amendments to INDs/CTAs and IMPDs as required
- Participate in new drug submission preparation and planning activities for marketed product readiness
- Participate in ensuring timely safety reporting to regulatory agencies;
Knowledge and Skills:
- Minimum BSc with at least 5-7 years’ experience in a regulated environment; MSc or PhD highly desired
- Experience in filing and maintaining INDs, CTAs, IMPDs, NDA/BLA in US, Canada, and Europe
- Must have knowledge of FDA guidelines. Direct FDA experience is a big plus.
- Must have strong experience with eCTD submissions
- CMC knowledge a plus
- Must be proficient in French and English
- Excellent public speaking and presentation skills
- Proficiency in Microsoft Office applications