Compliance Specialist, Global Regulatory CMC
celgene - Basking Ridge, NJ

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Prerequisites: BS/BA degree in Scientific Discipline with 1-3 years in the pharmaceutical industry or in CRO. RESPONSIBILITIES: Responsibilities will include, but are not limited to, the following: 1. With minimum supervision, interface with Regulatory Affairs EU and Regulatory CROs to track global regulatory approval status pertaining to CMC for all clinical programs. Communicate approval status with Investigator Material Supply Chain (IMSC) and other concerned functions in a timely manner.

2. With minimum supervision, represent Reg CMC to attend IMSC planning meetings for all development projects. Coordinate communications between Reg CMC product managers and IMSC Strategic Program Directors for clinical supply initiatives that may potentially have regulatory impact. Coordinate timelines and regulatory activities for initiatives that affect multiple projects.

3. Manage clinical change controls for Reg CMC by tracking regulatory action items through interface with Reg CMC product managers, IMSC leads and other concerned CMC functions. 4. Manage the official CMC information summary documents for clinical and commercial projects through Celgene's document management system eRexS.

Ensure that the summary documents are up to date. 5. With supervision, assure the accuracy of regulatory submissions by reviewing CMC documents against technical source documents (technical reports, validation reports, Master Batch Records, etc.), as needed. 6.

With supervision, maintain Regulatory CMC databases including tracking of global regulatory approval status for original NDA/MAA and subsequent supplements/variations, as needed. 7. With supervision, prepare CMC submission documents and coordinate supporting activities as required. Skills/Knowledge Required: Good understanding of quality and compliance aspects of pharmaceutical development and manufacturing.

Previous experience in a compliance/regulated role highly desirable.Understanding of either the drug development process or clinical supply activities.Experience with CMD regulatory documents preferred.Detail oriented. Strong organization skills.proven experience as a team member who has a history of providing strong individual and team contributions on complex departmental projects and within cross-functional teams.Excellent grammar and communication skills, both writter and oral.

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Celgene is delivering innovative therapies to patients with unmet medical needs in cancer and inflammatory diseases.