Job Details

  • Title: Regulatory Specialist - Global Regulatory CMC Biologics
  • Code: RCI-9812
  • Location: Summit New Jersey (NJ) 07901
  • Posted Date: 09/25/2020
  • Duration: 12 Months
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  Job Description

Client is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture

 

The Consultant will be based in Summit, NJ and 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