Veterinary Regulatory Compliance Specialist

2 weeks ago


Mumbai, Maharashtra, India Ashish Life Science Pvt Limited Full time
Job Summary

The Assistant Manager of Regulatory Affairs is a key role in our pharmaceutical company, responsible for ensuring regulatory compliance and submission activities within the formulation manufacturing division. This position involves preparing, compiling, and reviewing regulatory submissions, maintaining documentation, and coordinating with various departments to ensure timely submissions.

Main Responsibilities
  • Regulatory Submissions:
    • Prepare, compile, and review regulatory submissions, including ANDAs, NDAs, CTDs, and other dossiers required for product approval.
    • Ensure timely submission of dossiers to regulatory authorities (e.g., FDA, EMA, MHRA, etc.).
    • Coordinate with R&D, Quality Assurance, and Manufacturing teams to gather necessary documentation for submissions.
  • Regulatory Compliance:
    • Ensure that all products comply with the regulatory requirements of the target markets.
    • Review and approve product labeling, packaging, and promotional materials for compliance with regulatory standards.
    • Maintain up-to-date knowledge of current and changing regulations in key markets.
  • Documentation and Record Keeping:
    • Maintain accurate and comprehensive regulatory documentation, including product master files, technical files, and registration certificates.
    • Update and manage regulatory databases to track submission statuses, approvals, and regulatory commitments.
  • Regulatory Strategy:
    • Assist in developing regulatory strategies to support the timely approval and market launch of products.
    • Provide input on regulatory pathways for new products and lifecycle management of existing products.
    • Identify potential regulatory risks and provide mitigation strategies.
About Us

Ashish Life Science Pvt Ltd is a leading veterinary pharmaceutical company serving over 65 countries worldwide. With a team exceeding 30 veterinarians worldwide, we possess the expertise to deliver innovative solutions improving animal health and wellbeing.

Requirements

This role requires strong communication and collaboration skills, with the ability to work effectively across multiple departments. A high level of analytical skill, attention to detail, and the ability to manage competing priorities are essential. The successful candidate will have a deep understanding of regulatory requirements and the ability to stay up-to-date with changes in global regulatory environments.

We offer a competitive salary range of $80,000 - $120,000 per annum, depending on experience, plus benefits such as health insurance, retirement savings plan, and opportunities for professional development. If you are a motivated and experienced regulatory professional looking to join a dynamic team, please apply now.



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