Senior Regulatory Affairs Specialist

Major ResponsibilitiesResponsible for registration of medical device, IVDs and/or drug products.Responsible for the applications for New Product registration, variations of marketed products and license renewals within the set timeframe and conducting in compliance with NMPA/CMDE requirements as well as relevant internal SOP.Responsible for providing...

Job Summary:We are seeking a highly skilled Senior Regulatory Affairs 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...

About the RoleWe are seeking a highly motivated and experienced Regulatory Affairs professional to join our team at Novo Nordisk. As a Regulatory Affairs Manager, you will play a key role in ensuring the compliance of our products with regulatory requirements and ensuring the smooth approval process of new products.Key ResponsibilitiesDevelop and implement...

Job Purpose: Head of Regulatory Affairs will provide leadership and strategic direction for the GSK China Regulatory Affairs team. The role will ensure the registration of new products and line extensions and manage the life cycle of the products in line with commercial and global regulatory objectives. The role will maintain strategic stakeholder...

About BayerBayer is a global leader in the life sciences, driven by a vision to make a difference in the world by improving people's lives. We're a community of innovators, thinkers, and doers who are passionate about solving the world's toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real...

Are you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment. Apply now and join Novo Nordisk. Together we can create life-changing innovation. Together we can make it...

Key responsibilities 重要职责 Regulatory strategy development and execution for drug shortage Regulatory Planning and Development Strategy Submissions and Approvals for New Products Product Life Cycle Management Management and people development Cross Functions/Departments Supporting Regulatory Influence Budget Planning and...

   Key responsibilities 重要职责 Regulatory strategy development and execution for drug shortageRegulatory Planning and Development StrategySubmissions and Approvals for New ProductsProduct Life Cycle ManagementManagement and people development Cross Functions/Departments Supporting Regulatory InfluenceBudget Planning and Control Education...

   Are you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment. Apply now and join  Novo Nordisk. Together we can create life-changing innovation. Together we can...

Role Purpose ： To provide strategic and technical regulatory support to line manager for the purpose of commencing and maximizing GSK China Vaccine business by facilitating the submission and approval in a timely and high-quality manner. Key Accountabilities/Responsibilities ： Play the critical role of providing strategic and technical...

Job SummaryWe are seeking a highly skilled and experienced Associate Director to join our Regulatory Affairs and Compliance team at Pfizer. The successful candidate will be responsible for leading the development and implementation of regulatory strategies for our CMC products, ensuring compliance with regulatory requirements and industry standards.Key...

Description Regulatory Affairs Lead, China PDT is responsible for supporting the PDT BU’s global plasma sourcing strategy for China. S/he also leads local regulatory policy initiatives related to plasma and plasma sourcing to help ensure network flexibility and continuous supply of PDTs to patients in need in China. The Regulatory Affairs Lead,...

JOB DESCRIPTION Job Title Regulatory Affairs Manager Job Description Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. But it’s not just what we do, it’s who we are. We...

Job TitleRegulatory Affairs ManagerJob DescriptionPhilips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.But it’s not just what we do, it’s who we are. We are 80,000, wonderfully...

Position Overview: The incumbent will play a pivotal role in assisting the management team in fostering communication with certification and testing authorities. This position involves overseeing documentation and information pertaining to regulatory and accreditation entities. The responsibilities will be executed within the framework of the BV Health,...

Job SummaryThe Medical Affairs Effectiveness Specialist will be responsible for reviewing and managing external funding risk through effective models and procedures. This role will work closely with internal teams to improve efficient pre-approval processes and develop corporate risk strategies.Key ResponsibilitiesParticipate in medical governance...

Collaborate with cross-functional teams to establish quality assurance (QA) strategies aligned with regulatory requirements and industry best practices, which includes perfecting quality standards and implementing quality continuous improvement. Ensure effective communication style and collaborate with stakeholders: work closely with sales, modality,...

Description To prepare and submit regulatory application to obtain approval including for new products and the existing licenses renewal & variation. To monitor regulation change and analyze the change impact to the company. To be responsible for product testing in NMPA lab. Key Responsibilities    Work with function teams for all registration...

At Bayer, we are innovators committed to addressing the world's most pressing challenges, working towards a future where 'Health for all, Hunger for none' becomes a reality. Our journey is fueled by energy, curiosity, and unwavering dedication, as we learn from diverse perspectives, broaden our horizons, enhance our skills, and redefine what is possible....

At Bayer, we are innovators committed to addressing the world's most pressing challenges, striving for a reality where 'Health for all, Hunger for none' is achievable. Our journey is fueled by energy, curiosity, and unwavering dedication, as we learn from diverse perspectives, broaden our understanding, enhance our skills, and redefine what is possible....