- Title: Consultant - Global Regulatory CMC Biologics/Cell Therapy
- Code: RCI-32937-1
- Location: Summit New Jersey (NJ) 07901
- Posted Date: 09/16/2020
- Duration: 6 Months
Talk to our Recruiter
- Name:Vishal Trivedi
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 435
- The Consultant will be based in Summit, NJ and will assist the Regulatory-CMC Biologics/Cell Therapy team with projects to support department goals and objectives.
- Attention to detail, excellent organization skills, good verbal and written communication skills are required.
- Ability to work independently on routine assignments with daily check-ins and to work cooperatively with senior staff providing key assistance on complex assignment.
- Computer experience must include familiarity with Word, Excel and PowerPoint.
- Support Regulatory CMC Biologics & Cell Therapy group in the preparation of submissions.
- These submissions include briefing books, IND/CTA, BLA, MAA and global biologic applications.
- Must have 7-9 years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA, with a minimum of 5 years of Biologic/Cell Therapy Regulatory CMC experience, including the preparation of Biologic/Cell Therapy CMC dossiers
- At least a bachelor’s degree required. Master’s Degree or PhD preferred
- Extensive experience with Biologic/Cell Therapy 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