Job Description

Job Title： Global Regulatory Affairs Operation Sr.Manager

Location： US (Prefer CA & New Jersery)

Job Purpose

This position belongs to Global regulatory affairs department, serving the global Market which encompasses China US, EU, AUS and others. This role requires a detail-oriented professional who can oversee all regulatory affairs and quality assurance activities, ensuring compliance with local and international regulations. This role is responsible for successfully delivering project management capabilities for cross-functional teams of medium- to high-complexity within and across the Regulatory Affairs organization. The individual combines knowledge of scientific, regulatory, and business processes to properly drive the execution of Innovent’s regulatory strategies.

Main Duties

1. Ensure quality management system is well established and implemented in TCM RA.
2. Identifies the needs for best practices, processes, SOPs, tools, training sessions and designs related activities. Build systemic processes.
3. Maintaining the Veeva Vault RIM system and ensuring that all regulatory records are up to date.
4. Managing the change control process in Veeva Vault RIM
5. Maintaining the Regulatory shared drive and ensuring that all US/ex-US submissions and correspondence files are up to date
6. Collaborating with the external publishing vendor for e-submission files and submission receipts
7. Managing the spreadsheet that lists all weekly/monthly regulatory submissions and communicates the information with the external publishing vendor
8. Maintaining templates and style guides for regulatory submissions
9. Formatting the regulatory documents according to the regulatory agency guidelines
10. Working closely with other members of the Regulatory team and provide support to their projects as needed
11. Participating in the development of standard operating procedures

Job Qualifications

1. Bachelor’s degree or above, major in biology, medicine or pharmacy related.
2. At least 10 years related working experiences in regulatory affairs operations area.
3. Knowledge and experience of eCTD submissions.
4. Knowledge and experience with enterprise document management systems (eDMS), preferably Veeva regulatory information management.
5. Knowledge of U.S. and international regulations including cGMP, GCP, GPV, GLP, ICH guidance documents.
6. Knowledge and understanding of global industry standards, guidelines, and validation concepts, including eCTD format and registration tracking.
7. Strong learning ability.
8. Good project management skill and experience.
9. Be able to work with a keen sense of urgency and priority.
10. Good interpersonal and communication skills.

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