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Consultant, Global Regulatory Biologics Cell Therapy

Consultant, Global Regulatory Biologics Cell Therapy – Contract or CTP – Summit, NJ - $125.00-$150.00/hr
The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Pharmaceutical Company is seeking a Consultant, Global Regulatory Biologics Cell Therapy in Summit, NJ.

Role Description
Assist the Regulatory-CMC Biologics/Cell Therapy team with projects to support department goals and objectives. Job Responsibilities require the following skills: 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.

Skills & Requirements
• 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

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the Information Technology industry and market trends . Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

• Medical
• Dental
• Vision
• 401K
• Life Insurance ($20,000 benefit)

Nervous about an upcoming interview? Unsure how to write a new resume?

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Hays is an Equal Opportunity Employer.

Drug testing may be required; please contact a recruiter for more information.

Summary

Job type:
Contract
Industry
Technology & Internet Services
Location
Summit
Specialism
Infrastructure
Pay
$125.00-$150.00/hr
Ref:
1113496
Apply Now

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