Global Regulatory CMC Manager
Job Title:
Global Regulatory CMC Manager Job ID:
24-00701 Location:
Lawrenceville, NJ 08648 Duration:
06 Months on W2
Job Description:
Will consider candidates who can be based in either Lawrenceville or New Brunswick PREREQUISITES BS/BA degree in Scientific Discipline (Master's or higher preferred) with3-5
years in the pharmaceutical industry, preferably with 2
years CMC regulatory experience Responsibilities will include, but are not limited to, the following:
1.
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.
2.
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.
3.
Responsible for the global regulatory evaluation of CMC change controls with supervision.
4.
Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision.
5.
Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams.
6.
Participate in global regulatory interactions with health authorities, with supervision.
7.
Facilitate document review meetings and discussions.
8.
Develop and maintain knowledge of regulatory environment, regulations and procedures.
Skills/Knowledge Required:
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.
Recommended Skills Communication Drug Development Ich Guidelines Pharmaceuticals Problem Solving Project Management Apply to this job.
Think you're the perfect candidate? Apply on company site $('.
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on('click', function (event) window.
ExternalApply = window.
open('/interstitial?jobdid=j3p17w71s0rfw5cmycg', 'ExternalApply-j3p17w71s0rfw5cmycg'); ); Estimated Salary: $20 to $28 per hour based on qualifications.
Global Regulatory CMC Manager Job ID:
24-00701 Location:
Lawrenceville, NJ 08648 Duration:
06 Months on W2
Job Description:
Will consider candidates who can be based in either Lawrenceville or New Brunswick PREREQUISITES BS/BA degree in Scientific Discipline (Master's or higher preferred) with3-5
years in the pharmaceutical industry, preferably with 2
years CMC regulatory experience Responsibilities will include, but are not limited to, the following:
1.
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.
2.
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.
3.
Responsible for the global regulatory evaluation of CMC change controls with supervision.
4.
Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision.
5.
Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams.
6.
Participate in global regulatory interactions with health authorities, with supervision.
7.
Facilitate document review meetings and discussions.
8.
Develop and maintain knowledge of regulatory environment, regulations and procedures.
Skills/Knowledge Required:
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.
Recommended Skills Communication Drug Development Ich Guidelines Pharmaceuticals Problem Solving Project Management Apply to this job.
Think you're the perfect candidate? Apply on company site $('.
external-apply-email-saved').
on('click', function (event) window.
ExternalApply = window.
open('/interstitial?jobdid=j3p17w71s0rfw5cmycg', 'ExternalApply-j3p17w71s0rfw5cmycg'); ); Estimated Salary: $20 to $28 per hour based on qualifications.
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