Senior Consultant, Regulatory Affairs
Remote - United States
We are seeking candidates to actively contribute to and support the Regulatory Affairs activities to ensure all client's services comply and meet regulatory requirements. This new hire will report into the Director and will be required to provide regulatory guidance on projects including regulatory strategy, requirements for clinical studies, marketing approval in both domestic and international markets, strategic development plans, and Health Authority interactions. Looking for experienced regulatory affairs professionals to work cross-functionally to represent specific clients; someone who brings positive and productive working relationships between team members and department representatives. Will have the opportunity to manage or mentor new employees and provide management support to ensure acceptable resourcing of projects.
- Lead assigned submission tasks with very little supervision to prepare routine correspondences, INDs/CTAs, BLAs/NDAs/MAAs, annual reports, IND/CTA amendments, orphan drug applications, etc.
- Lead & support Health Authority interactions with the following: briefing document prep, coordination of meetings, preparations with subject matter experts, and documentation of minutes.
- Support submissions of regulatory documentation including all work with CROs and partners to ensure timely submission.
- Participates in cross-functional sub-teams representing RA and promoting positive and productive working relationships between project team members and RA representatives.
- B.S. degree in a scientific discipline or equivalent with a minimum of 12 years of applicable regulatory affairs experience in a biotech and/or pharma setting
- Experience across different therapeutic areas including but not limited to Oncology, Cardiovascular, Cell, and Gene Therapy, Immuno-Oncology
- Working knowledge of US, EU, and ICH regulatory requirements supporting program-level strategic activities spanning from pre-IND through to marketing product approvals
- Experience with the US and ex-US clinical trial submissions
- Experience with the interpretation of regulations, guidelines, and policy statements