Cmc Regulatory Affairs Product Specialist Jobs in Beijing

You will be responsible for medical device regulatory affairs activities in China for Apple Health. You will demonstrate the ability to develop a variety of solutions to RA/QA challenges and will exercise independent judgment in settling and communicating appropriate regulator action and engagement...

Job DescriptionPosition title: Manager CMC Regulatory AffairsDepartment: Regulatory AffairsReport to: Associate Director of CMCLocation: Beijing/Shanghai ChinaResponsibilitiesTake CMC lead for products under clinical development and for marketed drug products. Coordinate various aspects of CMC regul...

Are you looking for a role where you can showcase your process improvement skills If so this is the job for you.As Regulatory Affairs Management Professional you will be responsible for leading a process improvement effort across the organization focusing on business alignment cost and cycle time re...

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim...

Career CategoryRegulatoryJob DescriptionJob Summary: n Develop China registration strategy and implement regulatory submissions (China IND/CTN etc.) for products within Amgens portfolio in compliance with corporate standards and local regulatory requirements. n Develop HA communication strategy for...

Career CategoryRegulatoryJob DescriptionJob Summary: n Develop China registration strategy and implement regulatory submissions (e.g. China IND/ CTN etc.) for products within Amgens portfolio in compliance with corporate standards and local regulatory requirements. n Develop HA communication strateg...

Working with UsChallenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthrou...

Job DescriptionResponsibilities:Collaborate closely with global colleagues to prepare dossiers for veterinary medicine product registration in China (e.g. variations renewals GMO applications) providing guidance on Chinese regulatory requirements and conducting regulatory assessments.Support regulat...

Do you thrive in regulatory environments and have a passion for building trusted relationships with government and internal stakeholders Are you looking for a role where your bilingual skills and attention to detail can make a meaningful difference in a global mission-driven organisationJoin CFA Ins...

You will lead medical device regulatory affairs activities in China for Apple Health. You will demonstrate the ability to develop a variety of solutions to RA/QA challenges and will exercise independent judgment in settling and communicating appropriate regulator action and engagement strategy. Key...

3-4 years RA experience in medical devicesMedical or related education background and knowledgeGood communication skills in both Chinese and EnglishEffective time management skillsWell computer operation skills-Product registration related including new extension and changes:Document requirementSamp...

-Product registration related including new extension and changes:Document requirementSample ordering and type testingDossier preparationSubmissionFollowing up CMDE evaluation proceduresSolving various problems in whole processMaintaining database like RA database MDRiMFiling dossiers with consisten...

-Product registration related including new extension and changes:Document requirementSample ordering and type testingDossier preparationSubmissionFollowing up CMDE evaluation proceduresSolving various problems in whole processMaintaining database like RA database MDRiMFiling dossiers with consisten...

to J&J credo and industry code of conduct ethics and good regulatory practices comply with local legislations and global regulatory policies. Science WorkLead China Regulatory Science team and collaborate with other group leaders to coordinate and facilitate shaping and improving the China regulato...

At least bachelor degree on medical pharmaceutical biology or related regulatory legal or medical management master degree is preferred.At least 12-15 years working experience and 5 years leadership experience in regulatory science or other related areas in healthcare industry.Solid knowledge and ex...

to J&J credo and industry code of conduct ethics and good regulatory practices comply with local legislations and global regulatory policies. Science WorkLead China Regulatory Science team and collaborate with other group leaders to coordinate and facilitate shaping and improving the China regulato...

Job DescriptionPosition title: Manager CMC Regulatory AffairsDepartment: Regulatory AffairsReport to: Associate Director of CMCLocation: Beijing/Shanghai ChinaResponsibilitiesTake CMC lead for products under clinical development and for marketed drug products. Coordinate various aspects of CMC regul...

Job DescriptionResponsibilities:Work closely with Global colleagues to prepare dossiers and documents for product registration in China. Provide guidance and regulations required by the Chinese authorities for the documentation preparations. Independently undertake theproject.Work closely with inter...

University Degree in Pharmacy Biology Chemistry or related Life SciencesMinimum 3 years experience in OTC registrations (with thorough understanding of local NMPA regulations) - ability to critically analyse and apply knowledge to develop innovative regulatory strategies. Multinational company exper...

University Degree in Pharmacy Biology Chemistry or related Life SciencesMinimum 3 years experience in OTC registrations (with thorough understanding of local NMPA regulations) - ability to critically analyse and apply knowledge to develop innovative regulatory strategies. Multinational company exper...