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?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is an Equal Opportunity Employer.

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


Job type:
Technology & Internet Services
Apply Now

Share Job