Regulatory CMC Director
2 weeks ago
Pfizer is seeking a highly skilled Regulatory CMC Director to join our team in China. As a key member of our GRS CMC China team, you will be responsible for leading the development and execution of global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle.
Main Responsibilities- Collaborate with cross-functional colleagues to leverage and share technical and regulatory knowledge, align expectations, and manage planning and monitoring activities to mitigate risks.
- Deliver high-quality regulatory submissions for projects across all aspects of drug development or manufacturing lifecycle.
- Maintain the expansive combination of CMC product information, market registration details, component-level dossier content, and compliance of an integrated regulatory change management process.
- Assure product compliance through timely and accurate maintenance of CMC submission documentation and product knowledge in Regulatory systems.
- Prepare regulatory assessments, develop, and contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle.
- BS, MS, or PhD degree in chemistry, biology, or related scientific disciplines; an advanced degree is preferred.
- Technical discipline with 9+ years of experience in the pharmaceutical industry, with relevant technical experience (QA, Technical Services, Operations, Manufacturing, or R&D) and 4+ years of pharmaceutical regulatory experience is desired.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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CMC Regulatory Lead
2 weeks ago
Beijing, Beijing, China Bayer Full timeYour Key ResponsibilitiesAt Bayer, we strive to make a significant impact on the worldAssociate RA CMC Director Key Tasks and ResponsibilitiesRegulatory Strategy and PlanningDevelop and implement regulatory strategies for marketed chemical and bio-products, CTA, NDA in China.Timely tracking and updating project QC testing and CMC review status.Foreseeing...
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CMC Regulatory Expert
2 weeks ago
Beijing, Beijing, China Novo Nordisk Full timeAt Novo Nordisk, we are seeking a CMC Regulatory Expert to join our team. This role will be responsible for regulatory planning and strategy development, including submissions and approvals for CMC issues relevant to new products, license renewals, variations, annual reports, and deregistrations.Key ResponsibilitiesDevelop and implement regulatory plans and...
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China Regulatory CMC Lead
4 weeks ago
Beijing, Beijing, China Bristol Myers Squibb Full timeTransforming Patients' Lives through ScienceBristol Myers Squibb is a global biopharmaceutical company that is transforming patients' lives through science. We are seeking a highly skilled and experienced Regulatory CMC Lead to join our team in China.Key Responsibilities:Ensure regulatory compliance with government policy and company required SOPs.Support...
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Senior Regulatory Affairs CMC Manager
2 weeks ago
Beijing, Beijing, China 1215 GlaxoSmithKline (China) Investment Co Ltd Full timeKey Responsibilities:As a Senior Regulatory Affairs CMC Manager at 1215 GlaxoSmithKline (China) Investment Co Ltd, you will be responsible for providing strategic and technical regulatory input for the purpose of commencing and maximizing GSK China business by facilitating the CMC submission and approval in a timely and high-quality manner.Key...
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Regulatory Affairs Manager
2 days ago
Beijing, Beijing, China Bristol Myers Squibb Full timeTransform Your Career with Bristol Myers SquibbBristol Myers Squibb is a company that transcends the ordinary. We're not just another pharmaceutical company; we're a group of innovators, researchers, and problem solvers who are passionate about transforming patients' lives through science.A Day in the Life of a Regulatory Affairs Manager - China CMCAs a...
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Regulatory Affairs Director
4 weeks ago
Beijing, Beijing, China Bayer Full timeAt Bayer, we're driven to solve the world's toughest challenges and strive for a world where health for all and hunger for none is a real possibility.Associate RA CMC DirectorYour Key ResponsibilitiesDevelop and implement strategies for marketed chemical and bio-products in China, including dossier preparation, QC testing, and timely tracking of project...
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Senior Regulatory Affairs Manager CMC
4 weeks ago
Beijing, Beijing, China 1215 GlaxoSmithKline (China) Investment Co Ltd Full timeJob Summary:We are seeking a highly skilled Senior RA CMC Manager to join our team at 1215 GlaxoSmithKline (China) Investment Co Ltd. As a key member of our regulatory affairs team, you will be responsible for providing strategic and technical CMC regulatory input to support the development and approval of new and existing products.Key...
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Beijing, Beijing, China 1215 GlaxoSmithKline (China) Investment Co Ltd Full timeAbout the RoleWe are seeking a Senior Manager CMC Regulatory Affairs Professional to join our team at 1215 GlaxoSmithKline (China) Investment Co Ltd.Job SummaryThis role is responsible for providing strategic and technical regulatory input for new and established products, ensuring timely and high-quality CMC submissions and approvals in China.Key...
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Regulatory Affairs Director
2 days ago
Beijing, Beijing, China Bayer Full timeOverviewBayer, a global leader in healthcare and agriculture, is seeking an experienced Regulatory Affairs Director to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the successful registration and compliance of our chemical and biopharmaceutical products in China.
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Regulatory Affairs Manager
4 weeks ago
Beijing, Beijing, China Pfizer Full timeJob SummaryPfizer is seeking a highly skilled Regulatory Affairs Manager to join our team in China. The successful candidate will be responsible for leading the development and implementation of regulatory strategies for our CMC products, ensuring compliance with China regulations and guidelines.Key ResponsibilitiesDevelop and implement regulatory strategies...
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China Head Regulatory Compliance Manager
2 weeks ago
Beijing, Beijing, China Bristol Myers Squibb Full timeTransforming Patients' Lives through ScienceAt Bristol Myers Squibb, we are dedicated to developing innovative treatments that improve the lives of patients around the world. We are seeking a highly skilled CMC Regulatory Affairs Expert to lead our China operations and ensure compliance with regulatory requirements.Key Responsibilities:Develop and...
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Regulatory Affairs Manager
2 days ago
Beijing, Beijing, China Pfizer Full timeAbout the RoleThis is an exciting opportunity for a seasoned Regulatory Affairs professional to join Pfizer's Global Regulatory Solutions (GRS) team in China. As a key member of our GRS CMC China team, you will play a crucial role in ensuring compliance with regulatory requirements and guidelines across various jurisdictions.Key ResponsibilitiesServe as a...
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Regulatory Compliance Specialist
2 weeks ago
Beijing, Beijing, China PATH Full timePATH is seeking a highly experienced Regulatory Compliance Specialist to support the vaccine manufacturing industry in China and Southeast Asia. Key responsibilities include strengthening cGMP activities and capabilities of vaccine and drug manufacturers, providing technical and manufacturing quality support, and building strong collaborative relationships...
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Strategic Regulatory Affairs Director
2 days ago
Beijing, Beijing, China 1215 GlaxoSmithKline (China) Investment Co Ltd Full timeJob DescriptionHead of Regulatory Affairs for GSK in China will provide leadership and strategic direction for the company's regulatory affairs team. The role involves ensuring the registration of new products and line extensions, managing the life cycle of products, and aligning with commercial and global regulatory objectives.About the RoleLead a team of...
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Head of Regulatory Affairs Director
1 month ago
Beijing, Beijing, China 1215 GlaxoSmithKline (China) Investment Co Ltd Full timeJob Purpose:As the Head of Regulatory Affairs, you will provide strategic direction and leadership to the GSK China Regulatory Affairs team. Your primary focus will be on ensuring the registration of new products and line extensions, as well as managing the life cycle of products in line with commercial and global regulatory objectives.Key...
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Director of Government Relations, China
4 weeks ago
Beijing, Beijing, China Duolingo Full timeAt Duolingo, we're on a mission to make education fun, free, and accessible to everyone. To help us achieve this goal, we're seeking a highly skilled Director of Government Relations, China to lead our engagement with key government stakeholders in China.The ideal candidate will have a proven track record of developing and driving government affairs...
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Service Director
4 weeks ago
Beijing, Beijing, China Shangri-La Full timeWe are seeking a highly skilled and experienced professional to fill the role of Service Director at Shangri-La.Key Responsibilities:Supervise and lead a team of professionals to achieve exceptional results.Develop and implement effective strategies to drive business growth and improvement.Collaborate with cross-functional teams to achieve common goals and...
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Medical Director
4 weeks ago
Beijing, Beijing, China Thermo Fisher Scientific Full timeMedical Director - NeuroscienceAs a Medical Director - Neuroscience at Thermo Fisher Scientific, you will play a critical role in providing medical support and advice for clinical trials and safety evaluation within the PPD Pharmacovigilance department.Key Responsibilities:Provide study, project, and program-specific medical monitoring and review...
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Beijing, Beijing, China Cummins Inc. Full timeJob Summary:The Director of China Central Quality and Supplier Quality will lead the development and implementation of quality systems and processes to ensure compliance with regulatory requirements and customer expectations.Key Responsibilities:Lead the quality function in China, including the development and implementation of quality systems and...
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Beijing, Beijing, China Duolingo Full timeAt Duolingo, we're passionate about education and making it accessible to everyone. We're seeking a skilled Government Relations Director for China Expansion to help us achieve our mission.This role is a unique opportunity to drive our engagement with key government stakeholders in China, building a regulatory environment that supports our goals. You will...