Cmc regulatory expert
3 weeks ago
Job Title: Chemistry, Manufacturing and Control Regulatory Expert -We are seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to join our team. This is a challenging role that requires a strong understanding of regulatory requirements and the ability to lead global CMC submission activities. The ideal candidate will have experience in formulating and leading global CMC regulatory strategies, authoring high-quality CMC documentation, and ensuring technical congruency and regulatory compliance.Key Responsibilities: Develop and implement global CMC regulatory strategies that balance business needs with regulatory requirements. Lead and manage global CMC submission activities, including planning, authoring, reviewing, coordination, and submission. Author and/or review high-quality CMC documentation for health authority submissions. Ensure technical congruency and regulatory compliance across all regions. Collaborate with cross-functional teams to identify and address quality and compliance issues. Prepare and communicate CMC risk management assessments and contingency plans. Requirements: Pharmaceutical industry experience with a focus on chemistry, manufacturing, and control. Strong knowledge of regulatory requirements and guidelines, particularly those related to CMC. Proven track record of leading global CMC submission activities. Excellent communication and project management skills. Bachelor's degree in a relevant field, such as pharmaceutical science or chemistry. Benefits: We offer a competitive salary and benefits package, including comprehensive health insurance and a 401(k) plan. Ongoing training and development opportunities to help you grow your career. A dynamic and collaborative work environment with a diverse team of professionals. Why Join Our Team? We are a leading company in the pharmaceutical industry, dedicated to delivering innovative medicines and improving patient outcomes. As a member of our team, you will have the opportunity to make a meaningful contribution to our mission and advance your career in a fast-paced and exciting industry.
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CMC Regulatory Expert
3 weeks ago
Hyderabad, Telangana, India beBeeRegulatory Full timeJob Title: Chemistry, Manufacturing and Control Regulatory Expert -We are seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to join our team. This is a challenging role that requires a strong understanding of regulatory requirements and the ability to lead global CMC submission activities. The ideal candidate will have...
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Cmc regulatory specialist
2 weeks ago
Hyderabad, Telangana, India BeBeeRegulatory Full timeJob Summary: -Regulatory professionals who specialize in chemistry, manufacturing, and control (CMC) activities prepare and publish regulatory documentation for submissions to health authorities. This involves interacting with these authorities on CMC-related questions to support the launch of new products or existing ones.Key Responsibilities: Develop a...
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Cmc Regulatory Specialist
3 weeks ago
Hyderabad, Telangana, India BeBeeRegulatory Full timeJob Summary: -Regulatory professionals who specialize in chemistry, manufacturing, and control (CMC) activities prepare and publish regulatory documentation for submissions to health authorities.This involves interacting with these authorities on CMC-related questions to support the launch of new products or existing ones.Key Responsibilities: Develop a...
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CMC Regulatory Affairs
2 days ago
Hyderabad, Telangana, India Freyr Solutions Full time ₹ 20,00,000 - ₹ 25,00,000 per yearPrimary Responsibilities:Responsible for finalizing the CMC regulatory strategies for assigned products (Biological products) and provide support to execute tasks independently in accordance with global regulations and guidance procedures.Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for...
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Regulatory Affairs CMC Manager
3 weeks ago
Hyderabad, Telangana, India Amgen Inc Full timeJob DescriptionLet's do this. Let's change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by:Driving continuous improvement of processes and...
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Regulatory Affairs Specialist
2 weeks ago
Hyderabad, Telangana, India beBeeCompliance Full time ₹ 1,80,00,000 - ₹ 2,50,00,000Job Title:Regulatory Affairs Specialist - CMC StrategyJob Summary:We are seeking a skilled professional to develop and execute CMC regulatory strategies for assigned products, ensuring global compliance.Key Responsibilities:Develop and execute comprehensive CMC regulatory strategies for assigned products across the product lifecycle.Lead the development,...
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Regulatory Affairs Specialist
2 weeks ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000Job Title:Regulatory Affairs Specialist - CMCJob Description:This position involves supporting submissions to regulatory authorities and managing the lifecycle of products. We are seeking a highly skilled Regulatory Affairs Specialist to join our team.Key Responsibilities:Prepare, review, and compile high-quality regulatory submissions in electronic format,...
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Regulatory Affairs CMC Associate
2 weeks ago
Hyderabad, Telangana, India Ztek Consulting Full timeJob Description – Regulatory Affairs CMC Associate (US Market)We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities.Key Responsibilities:- Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.- Maintain...
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Regulatory Affairs CMC Associate
2 weeks ago
Hyderabad, Telangana, India Ztek Consulting Full timeJob Description – Regulatory Affairs CMC Associate (US Market)We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities.Key Responsibilities:Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.Maintain...
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Regulatory Affairs Manager – Cmc
2 weeks ago
Hyderabad, Telangana, India Vueverse. Full timeKey Responsibilities: Lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing.Oversee compilation and submission of Annual Reports, amendments, and deficiency responses.Interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and data.Review...
