Associate Regulatory Affairs Manager
1 month ago
Data de publication: Apr 8 2024
Role Purpose：
To provide strategic and technical regulatory support to line manager for the purpose of commencing and maximizing GSK China Rx business by facilitating the submission and approval in a timely and high-quality manner in Infection Disease (ID) therapeutic area.
Key Accountabilities/Responsibilities：
- Provide strategic and technical regulatory input and support to line manager to contribute for decision making on drug development strategy and license maintaining strategy to deliver the highest value to business.
- Independently compile high quality filing document complying with external and internal requirement to provide right and clear drug profile and data to NMPA to achieve targeted NDA/CTA/Renewal/Variation to be approved and life-cycle management.
- Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to responsible products.
- Independently engage with internal and external stakeholders to follow up every milestone closely to ensure issue identified, escalated, resolved timely and target filing and approval timeline plan is achieved.
- Establish and maintain a good relationship with key regulatory authority in daily work such as NMPA, CDE, NIFDC, CPC, etc. via professional communication.
- Make sure line manager fully informed products registration status in daily work.
- Support line manager on budget planning and monitoring in daily work.
- Provide timely and high-quality regulatory support and input to internal key stakeholders as needed.
- Ensure timely and flawless implementation of company SOP and compliance requirement in daily work.
Qualifications/Requirements: (Education / Experience / Competencies)
- A minimum of bachelor’s degree in chemistry or biological or pharmacy.
- Minimum 4 years’ experience in regulatory affairs field and at least 3 years in MNC.
- Proven ability to communicate (written/oral) with various functions and with authority.
- Fluency in English.
- Ability of cross functional co-operation. Strong ownership and cross boundary working mindset
- A strong capability in problem solving.
- Strong ability of lobby, influence and negotiation.
Notre objectif est d'être l’une des entreprises les plus innovantes, les plus performantes et dignes de confiance de l'industrie pharmaceutique. Nous pensons que nous apportons quelque chose d'unique chez GSK et lorsque nous associons nos connaissances, nos expériences et nos styles, l'impact est incroyable. Venez rejoindre notre aventure chez GSK où vous trouverez l'inspiration pour faire au mieux votre travail pour nos patients et pour nos clients. Un endroit où vous pouvez vous recentrer, vous sentir bien et aller de l'avant.
Avis important à l'attention des sociétés de recrutement/agences pour l'emploi
GSK n'accepte pas de recommandations provenant de sociétés de recrutement/agences pour l'emploi en ce qui concerne les postes à pourvoir sur ce site. Toutes les sociétés de recrutement/agences pour l'emploi doivent contacter les services des ressources humaines/des achat généraux et commerciaux de GSK pour obtenir une autorisation écrite préalable avant de recommander des candidats à GSK. L'obtention d'une autorisation écrite préalable est une condition préalable à tout accord (oral ou écrit) entre la société de recrutement/l'agence pour l'emploi et GSK. En l'absence d'une autorisation écrite, toute action de la part de la société de recrutement/l'agence pour l'emploi sera jugée comme ayant été effectuée sans le consentement ou l'accord contractuel de GSK. GSK ne pourra par conséquent pas être tenue responsable des frais découlant de ces actions ou des frais découlant de recommandations par des sociétés de recrutement/agences pour l'emploi en ce qui concerne les postes à pourvoir sur ce site.
-
Regulatory Affairs Sr. Manager
3 weeks ago
Beijing, Beijing, China Amgen Full timeThe Senior Manager Regulatory Affairs at Amgen is responsible for developing and executing regulatory strategies for product development projects. They ensure compliance with domestic and international regulatory requirements and liaise with regulatory agencies.
-
Beijing, Beijing, China Peak Recruitment Full timeBeijing, China (Hybrid)Our client is a global leader in providing integrated solutions to the crop science industry.The Regulatory Affairs Manager APAC is a newly created role for our client's China operations and will be a key role in developing, implementing, and leading regulatory strategies for our client's innovative pre and post harvest products...
-
Beijing, China Peak Recruitment Full timeâBeijing, China (Hybrid)Our client is a global leader in providing integrated solutions to the crop science industry.The Regulatory Affairs Manager APAC is a newly created role for our clientâs China operations and will be a key role in developing, implementing, and leading regulatory strategies for our clientâs innovative pre and post...
-
Sr. Regulatory Affairs Specialist
1 week ago
Beijing, China Abbott Laboratories Full timeMAJOR RESPONSIBILITIES: Responsible 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...
-
Sr. Regulatory Affairs Specialist
2 weeks ago
Beijing, China Abbott Full timeMAJOR RESPONSIBILITIES: Responsible 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...
-
Beijing, China Takeda Full timeDescription 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,...
-
Regulatory Affairs, Van
2 weeks ago
Beijing, China Mercedes-Benz Full timeTätigkeitsbereich:Forschung & Entwicklung incl. DesignFachabteilung:Certification and Regulatory Affairs ChinaGesellschaft:Mercedes-Benz Group China Ltd.Standort:Mercedes-Benz Group China Ltd., BeijingStartdatum:sofortVeröffentlichungsdatum:..4Stellennummer:MERQQArbeitszeit:Vollzeit Join usAufgaben Objective of job • Monitor China regulation/standard...
-
Senior Regulatory Affairs Specialist
2 days ago
Beijing, China Stryker Full timeAre you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the...
-
Senior Manager, Policy
4 weeks ago
Beijing, China Pfizer Full timeJob Title: Senior Manager, Policy & Public Affairs China Location: Beijing, China Reports To: Jessie Cheng, Director of Policy and Public Affairs, PPA Local team Position Summary This position is responsible for Pfizer’s in-market engagement with the local government authorities in North China, to shape Pfizer’s operating environment,...
-
Beijing, China Société Générale Assurances Full timeAssociate, Regulatory Reporting Permanent contract|Beijing|Finance Associate, Regulatory Reporting Beijing, China Permanent contract Finance Responsibilities Job Summary: This position is mainly responsible for regulatory reporting related tasks. The candidate is expected to apply analytical thinking and data analysis knowledge...
-
Beijing, Beijing, China bioMerieux SA Career Site - MULTI-LINGUAL Full time岗位设立的目的及目标/ PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB Responsible for establishing strategic direction of government affairs, representing the organization's position/value by interactingg with government entities and officials while advocating for the best interests of the organization and facilitate the smooth market access;...
-
External Affairs Partner
1 day ago
Beijing, Beijing, China Straumann Full timeExternal Affairs Partner Location: Beijing, ChinaReporting line: Tender (External Affairs) Manager Job SummaryThis position is responsible for the development of external affairs strategic target and tenet, focus on policies of product coding, pricing, procurement, and reimbursement, establish and maintain governmental communication. Collaborate with...
-
Beijing, China bioMérieux Full time岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB Responsible for establishing strategic direction of government affairs, representing the organization's position/value by interactingg with government entities and officials while advocating for the best interests of the organization and facilitate the smooth...
-
Beijing, China bioMerieux SA Career Site - MULTI-LINGUAL Full time岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB Responsible for establishing strategic direction of government affairs, representing the organization's position/value by interactingg with government entities and officials while advocating for the best interests of the organization and facilitate the smooth market access;...
-
Associate Director I, External Affairs
1 month ago
Beijing, China AIA Full timeFIND YOUR 'BETTER' AT AIA If you believe in better, we’d love to hear from you. About the Role Responsible for managing relationships and communications between AIA and relevant government authorities • Develop and maintain policies and programmes to ensure organisational awareness of government legislation and / or regulatory issues that affect...
-
Beijing, China ERM Full timeERM Libyro , is a compliance platform that helps global organizations know their Environmental and Health and Safety regulatory requirements; understand their obligations; and show their compliance. Since 2016, Libryo has helped thousands of users to navigate their compliance and improve their ESG performance and is now part of ERM, the world’s largest...
-
Senior Manager, Central Government Affairs
4 weeks ago
Beijing, China Biogen Full timeCompany Description At Biogen, our mission is clear - we are pioneers in neuroscience. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Together, our employees create, commercialize, and manufacture transformative therapies for our patient population. ...
-
Beijing, China HSBC Full timeWe are currently seeking an experienced professional to join our team. In this role, you will: ·To support, coordinate and oversight the delivery of regulatory data reporting requirement; ·To identify, develop and coordinate the implementation of standards, policies and procedures of regulatory data reporting; ·To maintain and improve data...
-
Project Manager, Medical Affairs
4 weeks ago
Beijing, China Novo Nordisk Full timeKey responsibilities 重要职责Responsible for the company KOL list validation, update and maintain, owner of the KOL database which supporting various systemsMA team external and internal project operation. Responsible for the activity plan, organization, coordination and budget controlSet up and maintain FMA team work tracking systemClosely...
-
Associate Product Manager
4 weeks ago
Beijing, China Bayer Full timeAt Bayer we’re visionaries, driven to solve 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 possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
