Senior Regulatory Professional

1 week ago


Hartford, Connecticut, United States KVK Tech Full time
Job Summary

KVK Tech is a dynamic and growing company, and we are seeking a highly experienced Regulatory Group Leader to join our team.

The estimated salary for this role is $140,000 per year, based on industry standards and location.

About the Position:

This is an excellent opportunity to lead the development and implementation of regulatory strategies that drive business growth and success. As a Regulatory Group Leader, you will be responsible for managing regulatory submissions, collaborating with cross-functional teams, and ensuring compliance with industry regulations.

Key Responsibilities:

  • Develop and implement regulatory strategies that meet KVK Tech's business objectives.
  • Lead the preparation and submission of regulatory documents in compliance with cGMP requirements, FDA regulations, and industry best practices.
  • Collaborate with R&D, QC, and Production Managers to ensure seamless integration of regulatory strategies.
  • Train Regulatory Associates on regulatory procedures and guidelines.
  • Assist associates, coordinators, analysts, auditors, and specialists as needed.

Requirements:

  • Bachelor's Degree in Pharmacy, Chemistry, or a scientific discipline preferred.
  • Minimum 5 years of pharma experience preferred.
  • Strong communication and problem-solving skills.
  • Proficient with Adobe PDF, Microsoft Office, XML, eCTD tools, and advanced computer skills.
  • Continuous working knowledge of applicable FDA/ICH/DEA regulations and cGMP guidelines.


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