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Join to apply for the Global Regulatory CMC Manager role at Katalyst CRO 1 week ago Be among the first 25 applicants Join to apply for the Global Regulatory CMC Manager role at Katalyst CRO 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 Sign in to set job alerts for “Regulatory Manager” roles. Austin, TX $70,000.00-$80,000.00 3 weeks ago Austin, TX $110,000.00-$155,000.00 3 days ago Austin, TX $191,100.00-$258,500.00 1 week ago Senior Manager, Government and Regulatory Compliance Austin, Texas Metropolitan Area 6 days ago Austin, TX $125,700.00-$242,500.00 6 days ago Export Compliance Manager, Global Trade Services Austin, TX $66,800.00-$142,800.00 3 days ago Austin, TX $168,000.00-$172,788.00 1 hour ago Austin, TX $102,400.00-$204,100.00 5 hours ago Manager, Internal Controls and Compliance Austin, TX $112,960.00-$169,440.00 8 hours ago Austin, TX $100,500.00-$173,250.00 1 week ago Senior Export Compliance Manager, Global Trade Services Austin, TX $109,000.00-$185,000.00 5 days ago Senior Export Compliance Manager, Global Trade Services Austin, TX $109,000.00-$185,000.00 3 days ago Sr. Associate Counsel, Global Regulatory Affairs Austin, TX $176,800.00-$230,000.00 5 days ago Domain Assurance Manager, Functional Compliance, RCI Austin, TX $158,000.00-$235,000.00 2 weeks ago Deputy Executive Commissioner, Regulatory Services Division Austin, TX $13,760.66-$20,000.00 1 week ago Strategy and Operations Manager, Risk, Compliance and Integrity Austin, TX $137,000.00-$201,000.00 1 week ago Austin, Texas Metropolitan Area $160,000.00-$200,000.00 3 days ago Austin, Texas Metropolitan Area 5 days ago Environmental Compliance Manager (Remote - Intermountain and Southcentral) Austin, TX $98,742.00-$123,428.00 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. #J-18808-Ljbffr