Regulatory Specialist - CMC Biologics in Summit, NJ at Apex Life Sciences

Date Posted: 8/10/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Summit, NJ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    8/10/2018
  • Job ID:
    865540

Job Description


Description:

  • Assist the Regulatory-CMC Biologics team with projects to support department goals and objectives.

Responsibilities: 

  • 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 5-7 years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA, with a minimum of 1-3 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
  • 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. 

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.