CMC Regulatory Scientist II in Rahway, NJ at Apex Life Sciences

Date Posted: 6/1/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Rahway, NJ
  • Job Type:
    Science
  • Experience:
    Not Specified
  • Date Posted:
    6/1/2018
  • Job ID:
    854202

Job Description


Qualifications:

  • B.S. degree in Chemistry, Pharmacy or Engineering related field.
  • Minimum 3- 5 years Pharmaceutical CMC focused regulatory experience with most of the world filing emphasis.
  • Global experience preferred. Applicant should have experience conducting regulatory assessments, submission authoring and assembly using CTD structure, and eCTD lifecycle management.
  • Proven organizational skills and excellent written/verbal communication are required. Applicant should have demonstrated writing skills, attention to detail and problem solving skills.
  • Proficiency needed in MS Office programs (Word, Excel, Outlook).


Responsibilities:

  • The major responsibilities include preparing and updating CMC sections and ancillary GMP documentation for of global Marketing. Authorizations; executing regulatory filing strategies while ensuring that all regulatory documents are prepared accurately, completely and on-time; tracking project status and effectively communicating progress.
  • Applicant will be responsible for multiple project assignments with critical timelines.