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AD, Regulatory CMC (Biologics)

  • Job type Contract
  • Salary competitive
  • Location New Jersey, USA
  • Sector Pharma & Biotech

Title: Associate Director, Regulatory CMC (Biologics)

Location: New Jersey (onsite)

Duration: 1 Year (extendable)

Rate: To be discussed…

Job Overview:

The Associate Director, Regulatory CMC will assist the Regulatory-CMC Biologics 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.

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
  • 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

Sthree US is acting as an Employment Business in relation to this vacancy.