Product Approval Coordinator

1 day ago


Mumbai, Maharashtra, India Ashish Life Science Pvt Limited Full time
Job Title: Product Approval Coordinator

About Us:
Ashish Life Science Pvt. Limited is a pharmaceutical manufacturing company committed to improving animal health and wellbeing through innovative solutions. We have a team of dedicated professionals who value learning, empathy, and innovation. Our commitment to quality, customer satisfaction, and personalized service extends globally.

Job Description:
We are seeking an experienced Product Approval Coordinator to support our regulatory compliance and submission activities within the formulation manufacturing division. As a key member of our team, you will be responsible for ensuring that products meet all regulatory requirements for approval and market entry. This involves preparing, compiling, and reviewing regulatory submissions, maintaining documentation, and coordinating with various departments to ensure timely submissions.

Responsibilities:
• Prepare and submit regulatory dossiers, including ANDAs, NDAs, CTDs, and other required documents.
• Ensure timely submission of dossiers to regulatory authorities (FDA, EMA, MHRA, etc.).
• Coordinate with R&D, Quality Assurance, and Manufacturing teams to gather necessary documentation for submissions.

Requirements:
• Bachelor's degree in a relevant field (e.g., life sciences, pharmacy, law).
• Proven experience in regulatory affairs, preferably in the pharmaceutical industry.
• Strong knowledge of regulatory requirements and procedures in major markets (US, EU, India, etc.).
• Excellent communication and coordination skills.
• Ability to work under pressure and manage multiple tasks simultaneously.
• Estimated Salary: ₹900,000 - ₹1,200,000 per annum.

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