Regulatory Compliance Specialist
3 weeks ago
Job Overview
The Ashish Life Science Pvt Limited is seeking a highly skilled Assistant Manager of Regulatory Affairs to support the company's formulation manufacturing division in ensuring regulatory compliance and submission activities.
This role involves preparing, compiling, and reviewing regulatory submissions, including ANDAs (Abbreviated New Drug Applications), NDAs (New Drug Applications), CTDs (Common Technical Documents), and other dossiers required for product approval. The Assistant Manager will also be involved in monitoring regulatory changes, preparing dossiers, and communicating with regulatory bodies.
Key Responsibilities:
- Preparation and Submission of Regulatory Submissions
- Regulatory Compliance and Documentation
- Monitoring Regulatory Changes and Updates
- Collaboration with Internal Departments
Requirements:
To be successful in this role, you must have a strong understanding of regulatory requirements and experience in preparing and submitting regulatory documents. You should also possess excellent communication and interpersonal skills, as well as the ability to work effectively in a team environment.
Salary Range: $80,000 - $110,000 per annum, depending on experience.
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