Regulatory Compliance Specialist
2 months ago
Job Summary
The Regulatory Compliance Specialist assists with the maintenance of a portfolio of products in China, ensuring compliance with local and international regulatory requirements. This role involves preparing regulatory submissions, collaborating with internal teams, and maintaining knowledge of relevant legislation.
Key Responsibilities
- Prepare regulatory submissions for new products, variations, and clinical trials.
- Analyze data packages for compliance and identify discrepancies.
- Develop an overall perspective of registration projects.
- Respond to deficiency letters and submit data requirements within stipulated timeframes.
- Maintain contact with Chinese regulatory agencies.
- Update local product documents and artwork.
- Stay up-to-date with relevant legislation.
- Provide regulatory advice to company personnel.
Requirements
- Strong customer focus and excellent communication skills.
- Excellent teamwork and result-orientation.
- Quality orientation and ability to research information.
- Good working knowledge of international and local regulatory guidelines.
- Proficiency in Microsoft Office applications.
Personal Development
The Regulatory Compliance Specialist will have opportunities for training and development, including completing Pfizer's PRE Safety Reporting Process training module and attending regulatory and clinical development workshops.
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