Regulatory Affairs Specialist, Operation (FSP)

Accountabilities - 职责

• Coordinate and support regulatory submissions centrally.
• Provide efficient operational support for regulatory submission, including internal processes, e-stamping, publishing, and eGateway submission.
• China Regulatory Affairs registration document archiving management
• All legal registration documents and records (original and copies) are managed and stored in accordance with relevant standard operating procedures (SOPs).
• Maintenance of product information on the local tracker and HA platform
• Maintain BI product information on local tracker and HA platforms according to local regulations and internal SOP/LWI guidelines.
• Assist in developing and updating China's eCTD process.
• Provide support for China eCTD rollout as needed
• Provide training to the RA team as an AI tool pioneer.
• Deliver comprehensive AI tool training sessions to the RA team to enhance overall work efficiency.
• Provide other support as team needed
• Local implementation of new SOP, system timely etc.

Job Complexity - 复杂性 *

Understand the structure, key roles and responsibilities of internal and externalcustomers/stakeholders; Understand internal RA related SOPs and systems, and optimize the procedures andplatforms under the supervision of line manager.

Minimum Education/Degree Requirements

Bachelor degree or above

Major/Focus

Pharmaceutics, Chemistry, Biology and other relevant major

Required Capabilities (Skills, Experience, Competencies)

Good project management skill and experience. Be able to work with a keen sense of urgency and priority.2.Strong learning ability.3.Good personality with team spirit.4.Interpersonal and communication skill.5.＞1 year Regulatory Affairs working experiences and project management working experiences in international pharmaceutical companies.6.Experience using the Veeva database for document management or regulatory information management is preferred. Coordinate and support regulatory submissions centrally. China Regulatory Affairs registration document archiving management Maintenance of product information on the local tracker and HA platform Assist in developing and updating China's eCTD process. Provide training to the RA team as an AI tool pioneer. Provide other support as team needed

Accountabilities - 职责

• Coordinate and support regulatory submissions centrally.
• Provide efficient operational support for regulatory submission, including internal processes, e-stamping, publishing, and eGateway submission.
• China Regulatory Affairs registration document archiving management
• All legal registration documents and records (original and copies) are managed and stored in accordance with relevant standard operating procedures (SOPs).
• Maintenance of product information on the local tracker and HA platform
• Maintain BI product information on local tracker and HA platforms according to local regulations and internal SOP/LWI guidelines.
• Assist in developing and updating China's eCTD process.
• Provide support for China eCTD rollout as needed
• Provide training to the RA team as an AI tool pioneer.
• Deliver comprehensive AI tool training sessions to the RA team to enhance overall work efficiency.
• Provide other support as team needed
• Local implementation of new SOP, system timely etc.

Job Complexity - 复杂性 *

Understand the structure, key roles and responsibilities of internal and externalcustomers/stakeholders; Understand internal RA related SOPs and systems, and optimize the procedures andplatforms under the supervision of line manager.

Minimum Education/Degree Requirements

Bachelor degree or above

Major/Focus

Pharmaceutics, Chemistry, Biology and other relevant major

Required Capabilities (Skills, Experience, Competencies)

Good project management skill and experience. Be able to work with a keen sense of urgency and priority.2.Strong learning ability.3.Good personality with team spirit.4.Interpersonal and communication skill.5.＞1 year Regulatory Affairs working experiences and project management working experiences in international pharmaceutical companies.6.Experience using the Veeva database for document management or regulatory information management is preferred. Coordinate and support regulatory submissions centrally. China Regulatory Affairs registration document archiving management Maintenance of product information on the local tracker and HA platform Assist in developing and updating China's eCTD process. Provide training to the RA team as an AI tool pioneer. Provide other support as team needed

Accountabilities - 职责

• Coordinate and support regulatory submissions centrally.
• Provide efficient operational support for regulatory submission, including internal processes, e-stamping, publishing, and eGateway submission.
• China Regulatory Affairs registration document archiving management
• All legal registration documents and records (original and copies) are managed and stored in accordance with relevant standard operating procedures (SOPs).
• Maintenance of product information on the local tracker and HA platform
• Maintain BI product information on local tracker and HA platforms according to local regulations and internal SOP/LWI guidelines.
• Assist in developing and updating China's eCTD process.
• Provide support for China eCTD rollout as needed
• Provide training to the RA team as an AI tool pioneer.
• Deliver comprehensive AI tool training sessions to the RA team to enhance overall work efficiency.
• Provide other support as team needed
• Local implementation of new SOP, system timely etc.

Job Complexity - 复杂性 *

Understand the structure, key roles and responsibilities of internal and externalcustomers/stakeholders; Understand internal RA related SOPs and systems, and optimize the procedures andplatforms under the supervision of line manager.

Minimum Education/Degree Requirements

Bachelor degree or above

Major/Focus

Pharmaceutics, Chemistry, Biology and other relevant major

Required Capabilities (Skills, Experience, Competencies)

Good project management skill and experience. Be able to work with a keen sense of urgency and priority.2.Strong learning ability.3.Good personality with team spirit.4.Interpersonal and communication skill.5.＞1 year Regulatory Affairs working experiences and project management working experiences in international pharmaceutical companies.6.Experience using the Veeva database for document management or regulatory information management is preferred. Coordinate and support regulatory submissions centrally. China Regulatory Affairs registration document archiving management Maintenance of product information on the local tracker and HA platform Assist in developing and updating China's eCTD process. Provide training to the RA team as an AI tool pioneer. Provide other support as team needed