Katalyst CRO
Global Regulatory CMC Manager
Katalyst CRO - Lawrenceville, New Jersey, United States
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Overview
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Global Regulatory CMC Manager
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Katalyst CRO 4 months ago Be among the first 25 applicants Join to apply for the
Global Regulatory CMC Manager
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Katalyst CRO Get AI-powered advice on this job and more exclusive features. 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. Facilitate document review meetings and discussions. Develop and maintain knowledge of regulatory environment, regulations and procedures. Participate in the development of the CMC regulatory strategy for biologics submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.
Responsibilities
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. Facilitate document review meetings and discussions. Develop and maintain knowledge of regulatory environment, regulations and procedures. Participate in the development of the CMC regulatory strategy for biologics submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.
Requirements:
Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations. Experience in drug development processes and post-approval requirement. 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. Experience with CMC regulatory documents (IND/CTAs, BLAs, MAAs, responses and variations). Seniority level
Seniority level Associate Employment type
Employment type Contract Job function
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Global Regulatory CMC Manager
role at
Katalyst CRO 4 months ago Be among the first 25 applicants Join to apply for the
Global Regulatory CMC Manager
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. 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. Facilitate document review meetings and discussions. Develop and maintain knowledge of regulatory environment, regulations and procedures. Participate in the development of the CMC regulatory strategy for biologics submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.
Responsibilities
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. Facilitate document review meetings and discussions. Develop and maintain knowledge of regulatory environment, regulations and procedures. Participate in the development of the CMC regulatory strategy for biologics submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.
Requirements:
Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations. Experience in drug development processes and post-approval requirement. 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. Experience with CMC regulatory documents (IND/CTAs, BLAs, MAAs, responses and variations). Seniority level
Seniority level Associate Employment type
Employment type Contract Job function
Job function Legal Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Regulatory Manager jobs in
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Piscataway, NJ $100,000.00-$110,000.00 4 days ago Manager, Field Alert & Recall Compliance
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Whitehouse Station, NJ $85,000.00-$100,000.00 14 hours ago Princeton, NJ $120,000.00-$140,000.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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