Global Regulatory CMC Manager

ASK Consulting Lawrenceville, Georgia
regulatory cmc manager cmc regulatory supervision consulting regulatory strategy strategy supplements health cross functional regulations
November 24, 2022
ASK Consulting
Lawrenceville, Georgia
CONTRACTOR
  • Job Type:Contract

Posted about 19 hours ago




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: [email protected]


Phone: 470-483-1052


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