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Global Regulatory CMC Manager

Lawrenceville, NJ 08648

Posted: 02/06/2024 Job Number: 26266412 Pay Rate: 85.86-87.06 USD/Hour

Job Description

GLOBAL REGULATORY CMC MANAGER
LAWRENCEVILLE, NJ
Will consider candidates in either Lawrenceville or New Brunswick.
The pay ranges between $85.86 - $87.06/hr W2.

Required Skills:
  • BS/BA degree in Scientific Discipline (Master's or higher preferred) with 3-5+ years in the pharmaceutical industry, preferably with 2+ years CMC regulatory experience.
  • Experience with CMC regulatory documents (IND/CTAs, 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.

Project Description:
  • Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, 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 Margo: margo@alphaconsulting.Com

ALPHA'S REQUIREMENT #24-00190
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
#LI-ME1

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Margo Emling

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