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Regulatory CMC Associate Director

Location: Summit, New Jersey Salary: Up to US$85 per hour + competitive
Sector: Pharma & Biotech Type: Contract

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).

Job Duties:

* Support Regulatory CMC Biologics group in the preparation of submissions.

* These submissions include briefing books, IND/CTA, BLA, MAA and global biologic applications.

Qualifications:

* 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

Skills/Knowledge Required:

* 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.