Senior Manager, Regulatory Affairs China - Neuroscience

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Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Beijing, China

Job Description:

Essential Job Duties and Responsibilities


* Lead the development of regulatory strategies for R&D portfolios related to assigned projects, ensuring alignment with overall business objectives.


* Serve as the Regulatory lead, providing strategic regulatory input to China and global compound teams.

Responsible for the execution of CTA and BLA filings and so on, with a particular focus on large molecule products.

Lead the consultations with relevant Health Authorities.


* Act as the RA representative to offer regulatory expertise to local product teams and cross-functional teams to ensure compliance and strategic alignment.


* Ensure timely submission of regulatory filings and address any queries from Health Authorities promptly and effectively.


* Demonstrate keen awareness of Chinese regulatory policies and proactively integrate these insights into the regulatory strategy for applications.

Adapt strategies as needed to align with evolving regulations and guidelines.


* Establish and maintain strong relationships with regulatory authorities and key stakeholders within the local, regional, and global organization to facilitate effective communication and collaboration.

Stay updated on regulatory requirements and guidelines specific to large molecules, ensuring that all applications and submissions meet the necessary standards and regulations.

Summary of Job Responsibilities:

Dimensions of Job:

Strategic Influence:


* Develop and implement regulatory strategies that align with the business goals of the Neuroscience Therapeutic Area.


* Influence internal stakeholders and cross-functional teams to ensure regulatory considerations are integrated into project planning and execution.

Regulatory Expertise:


* Serve as the expert on regulatory requirements and guidelines specific to neuroscience products, including large molecules.


* Provide guidance on regulatory pathways and risk assessments to support product development and commercialization.

Project Leadership:


* Lead regulatory activities for multiple projects within the Neuroscience TA, ensuring timely and compliant submissions to regulatory authorities.


* Manage complex projects and prioritize tasks effectively to meet deadlines and achieve regulatory milestones....