
Regulatory Affairs Professional
2 days ago
We are seeking a highly skilled Regulatory Affairs professional to take on the responsibility of ensuring compliance with regulatory requirements.
- Preparation and review of Standard Operating Procedures (SOPs)
- Management of Quality Management System (QMS) activities
- Preparation and review of Drug Master File (DMF) documentation
- Knowledge of international and domestic audit practices
- Annual Product Quality Review (APQR) preparation
- Drugs Master File preparation
- Liaison with regulatory agencies
- Review and implementation of quality agreements
This is an exciting opportunity for someone who has a strong understanding of regulatory requirements and excellent communication skills.
Key Qualifications:- Experience working in the pharmaceutical industry
- Strong understanding of regulatory requirements
- Excellent communication and organizational skills
- Develop and implement regulatory strategies to ensure compliance
- Manage relationships with regulatory agencies
- Oversee the preparation and review of regulatory documents
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