Global biopharmaceutical client with a presence in more than 70 countries is seeking to hire an Associate Director of Global Regulatory CMC Biologics for a 1 year contract. This role will be based in Central, NJ.
The contractor will be based at the Summit, NJ site and will assist the Regulatory-CMC Biologics team with projects to support department goals and objectives.
Title: Global Regulatory CMC Biologics- Associate Director
Contract Length: 1 year
Compensation: hourly based, depending upon experience (medical, dental, vision, 401K offered to W2 contractors).
* Support Regulatory CMC Biologics 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 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
* 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.