Achieva Group Ltd

Associate Regulatory Affairs Manager

Location
Beijing
Salary
Not specified
Posted
09 Feb 2021
Closes
11 Mar 2021
Ref
BH-6001
Contact
Lewis Coulson
Hours
Full Time
Contract Type
Permanent
Experience Level
Management
The Associate Registration Manager assists with the regulatory maintenance of a portfolio of vaccine products. This includes the preparation of regulatory submissions to the Chinese authorities for registration of new products, variations to marketed products and clinical trial notifications, when required. The Associate Registration Manager will assist the line Managers on specific projects, and in some instances will be responsible for their own projects. The Associate Registration Manager ensures that each project operates within the set time frames, is conducted to the highest standards of quality and is in accordance with local and international regulatory agency requirements and Client’s Standard Operating Procedures. The Associate Registration Manager may also be required to assist on special projects for the Regulatory Affairs Group. Ensure optimal regulatory compliance in China.
 
Therapeutic Area: Vaccine
Scope of Work: pre-CTA for vaccine projects and CTA documentation preparation The Associate Registration Manager assists with the regulatory maintenance of a portfolio of vaccine products. This includes the preparation of regulatory submissions to the Chinese authorities for registration of new products, variations to marketed products and clinical trial notifications, when required. The Associate Registration Manager will assist the line Managers on specific projects, and in some instances will be responsible for their own projects. The Associate Registration Manager ensures that each project operates within the set time-frames, is conducted to the highest standards of quality and is in accordance with local and international regulatory agency requirements and Client’s Standard Operating Procedures. The Associate Registration Manager may also be required to assist on special projects for the Regulatory Affairs Group. Ensure optimal regulatory compliance in China.
 
Therapeutic Area: Vaccine
Scope of Work: pre-CTA for vaccine projects and CTA documentation preparation collaborate and Communicate with China PBG President on the ways to help the country meet annual objectives of different BUs and ensure regulatory supports to the marketing and sales effort through:


Responsibilities
·         Prepare the regulatory submissions for registration of new products, variations to marketed products and clinical trial applications, where required.
·         Critically analyse data packages for regulatory compliance and identify discrepancies in data presented and request additional data.
·         Develop an overall perspective of registration projects.
·         Prepare responses to deficiency letters and ensure that these and other data requirements are submitted to regulatory agencies within the stipulated or agreed time frames.
·         Maintain contact with officials of Chinese regulatory agencies to determine regulatory requirements, ensure compliance with the regulations and expedite approvals.
·         Maintain and update the Local Product Document (labeling) and Artwork in accordance with relevant regulations and Client SOPs
·         Maintain an up to date knowledge of the relevant legislation in China.
·         Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to company products.
·         Provide regulatory advice to company personnel as required.
·         Partner with the global regulatory and clinical development team in China PBG BUs for new products development strategy and inline products strategy.
·         Partner with PGS and Pharma Sciences for the implementation China GMP, Chinese Pharmacopeia (CHP) and other China regulatory requirements in PGS sites.
·         Partner with PGS for supply strategy to avoid supply issue due to site changes
·         Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirement, Client policies, procedures, and practices
Ensuring Regulatory Compliance
·         Ensure timely communicate  the requirement of CHP and other China regulations to PGS  QO and GCMC to facilitate the implement of CHP and other regulations in PGS sites
·         Ensure local process in place for the timely submission of all the quality and safety relevant variations including labelling safety update and  specification/manufacture process change
Special Projects
·         Be required to participate on special projects for the Regulatory Affairs Group
Market Support
·         Attend Regulatory Affairs, Medical Department and other internal meetings as required.
·         Provide a resource for other sections of the company for specified therapeutic areas.
Personal Development
·         Complete the Client PRE Safety Reporting Process: Overview training module in the set time frame.
·         Complete related Training.
·         Attend and actively participate in personal development courses as required.
·         Attend training in specific therapeutic areas as required.
Participate in Regulatory Affairs and Medical Department projects and workshops.

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