CMC Manager

SUMMIT, NJ

Posted: 08/01/2022 Job Number: 21314244

Job Description

CMC MANAGER
SUMMIT, NJ
Required Skills:
  • BS/BA degree in Scientific Discipline (Masters or higher preferred) with
    5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience.
  • Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations, and briefing documents).
  • Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations.
  • Experience in drug development processes and post-approval requirements.
  • Experience in developing CMC regulatory strategy.
  • Experience in project management.
  • Have a solution-oriented approach to problem solving.
  • Ability to plan/prioritize work of group members and guide/develop others.
  • Ability to work on complex projects and within cross-functional teams with supervision.
  • Excellent communication skills, both written and oral.
  • Change control (be able to work in CC systems i.E eQRMS, Infinity, Verity).

Project Description:
  • Participate in the development of the CMC regulatory strategy for small molecules, biologics, and cell therapy submissions.
  • These submissions include health authority briefing packages, IND/CTA, BLA/NDA, and MAA regulatory filings.
  • Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
  • Responsible for the global regulatory evaluation of CMC change controls with supervision.
  • Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision.
  • Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams.
  • Participate in global regulatory interactions with health authorities, with supervision.
  • Facilitate document review meetings and discussions.
  • Develop and maintain knowledge of regulatory environment, regulations, and procedures.


This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Jim: jim@alphaconsulting.Com

ALPHA'S REQUIREMENT #22-02301
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Meet Your Recruiter

Jim Pizzelanti

Apply Online

Send an email reminder to:

Refer A Friend

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.