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Global Regulatory CMC Manager

  • Location: Lawrenceville
  • Job Type:Contract

Posted about 1 month ago

  • Expiry Date: 08 December 2022
  • Referral: 219499@accuick.com

Job Description:

This role is 50% onsite/hybrid

PREREQUISITES 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
Responsibilities will include, but are not limited to, the following:

  • Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries.

  • Prepare and review CMC submission documents, registration dossiers, and responses to health authorities through collaborations with relevant line functions and with minimal supervision.

  • May be responsible for the global regulatory evaluation of CMC change controls with supervision.

  • Work with CMC cross-functional teams and Regulatory Affairs teams.

  • Develop and maintain knowledge of regulatory environment, regulations and procedures.

Skills/Knowledge Required:

  • Experience with CMC regulatory documents (global registrations, including NDAs, MAAs and others, responses and supplements/variations).

  • Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations.

  • Experience in 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.

  • Excellent computer skills.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

Contact:

Full Name: Savita Khashu

Email ID: savitak@askconsulting.com

Phone: 470-483-1052