Our client, a leader in the Biopharmaceutical industry is seeking a Regulatory Specialist with experience in CMC Biologics, to join their team on a 12-month contract basis. This individual must have a experience working with Cell Therapy, QA and dossier preparation.
Responsibilities include but is not limited to:
- Support Regulatory CMC Biologics group in the preparation of submissions, include briefing books, IND/CTA, BLA, MAA and global biologic applications.
- Ability to work independently on routine assignments with daily check-ins and to work cooperatively with senior staff providing key assistance on complex assignment
- Must have 7-9 years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA
- Minimum of 5 years of Biologic Regulatory CMC experience, including the preparation of Biologic CMC dossiers
- At least a Bachelor Degree required. Master's Degree or PhD preferred
- Extensive experience with Biologic CMC regulatory documents (MAA, BLA, supplements, meeting requests and briefing books responses and IND/CTAs)
- Experience with CMC regulations for biological compounds
- Experience with Gene/Cell/CAR T Cell therapy CMC regulations
- Practical knowledge of FDA, EMEA, Canadian and ICH guidelines.
- Practical knowledge of rest of world post approval guidelines
- Have a solution-oriented approach to problem solving
- Expertise in the drug development process and post approval activities
- Ability to work on complex projects and within cross-functional teams
Sthree US is acting as an Employment Business in relation to this vacancy.