China RA manager
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Job Summary
Responsibilities:
1Regulatory Submission Preparation & Execution
- Leadthe preparation review and compilation of high-quality regulatory dossiers (e.g. CTD/eCTD format) for product registrations variations renewals and other regulatory filings to NMPA and other global health authorities.
- Ensure accuracy consistency and compliance of submission documents with regional guidelines company SOPs and global regulatory standards.
- Coordinate with cross-functional teams (R&D CMC Clinical Quality Medical Affairs) to collect validate and consolidate technical and clinical data for regulatory submissions.
- Manage submission timelines track deliverables and resolve document-related issues to ensure on-time filing.
2Regulatory Compliance & Lifecycle Management
- Monitor and maintain regulatory compliance of registered products including tracking license renewals post-approval commitments and periodic safety update reports (PSURs)/periodic benefit-risk evaluation reports (PBRERs).
- Support the management of product variations (minor/major) and post-approval changes including preparing relevant documentation and liaising with regulatory authorities for review and approval.
- Keep abreast of the latest regulatory updates guidelines and policy changes from NMPA FDA EMA and other global agencies; conduct impact assessments and communicate key changes to the team and cross-functional stakeholders.
3Regulatory Communication & Liaison
- Act as a key point of contact for regulatory authorities (e.g. NMPA) for routine inquiries document supplements and review feedback during the submission and approval process.
- Prepare and respond to regulatory information requests (IRs) and deficiency letters in a timely and accurate manner in collaboration with technical teams.
- Support the organization of regulatory meetings (e.g. pre-submission meetings inspection preparations) and prepare meeting materials minutes and follow-up action plans.
4Document & Data Management
- Maintain accurate and up-to-date regulatory document repositories (e.g. eCTD databases regulatory information management systems) and ensure proper version control and archiving of all regulatory records.
- Compile and report regulatory metrics (e.g. submission timelines approval status compliance milestones) to the RA management team and global stakeholders.
- Support the development and update of company regulatory SOPs templates and guidelines to align with global and regional requirements.
5Cross-functional Collaboration & Global Alignment
- Collaborate with global RA teams to ensure consistency in regulatory strategies submission approaches and documentation across regions.
- Work closely with R&D CMC Clinical Operations and Quality teams to address regulatory requirements throughout the product development and commercial lifecycle.
- Provide regulatory guidance and support to internal teams on day-to-day regulatory queries and project-specific requirements.
Qualifications:
- Bachelors/Masters degree in Pharmacy Pharmaceutical Sciences Chemistry Biology Biotechnology or a related life science field; advanced degrees are a plus.
- above 5years of relevant regulatory affairs experiencein the pharmaceutical/biotechnology industry.
- Experience with CTD/eCTD dossier preparation regulatory submissions and post-approval lifecycle management is highly desirable.
- Familiarity with pharmaceutical product development (CMC clinical quality) is a plus.
- Regulatory Knowledge
- Working knowledge ofNMPA regulations and guidelines; basic understanding of FDA/EMA/PMDA regulatory requirements is an advantage.
- Familiarity with regulatory document formats (CTD/eCTD) PSUR/PBRER preparation and post-approval variation processes.
- Fluent inMandarinandEnglish oral and written
- Expert MS Office skills
- Excellent organizational time management and interpersonal skills in a global environment.
- Ability to work successfully in a complex matrix organization.
- Proven ability to work effectively both independently and in a team.
- The expertise determination and courage to resolve or escalate issues as appropriate.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being CSL.
You Belong at CSL
At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit Experience:
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Join the thousands of people who safely donate plasma each week at CSL Plasma and get rewarded for your time.
