Senior Regulatory Affairs Lead
2 days ago
Job Description:
Regulatory Affairs Manager for Pharmaceutical Industry
Welcome to the Abbott team as a Regulatory Affairs Manager for Pharmaceutical Industry We are looking for a highly skilled and experienced professional to join our team.
About the Role:
- Develop and implement regulatory strategies to ensure timely product approvals and compliance with CFDA regulations and guidelines.
- Prepare and validate registration dossiers for CTA, NDA, Renewal, and variations, ensuring that all necessary documentation is complete and accurate.
- Establish and maintain effective working relationships with regulatory authorities, including CFDA, CDE, and Institute for Drug Control.
- Provide regulatory support to Medical and Marketing teams, as well as other company personnel, to ensure compliance with regulatory requirements.
- Develop and implement internal processes and systems to support regulatory submissions and approvals in the most efficient manner.
- Train and develop subordinates, provide good support, and well coordinate with colleagues to promote the best performance of team work.
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