Regulatory Affairs Expert

1 day ago


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

KVK Tech is a leading pharmaceutical company seeking an experienced Regulatory Group Leader to join our team. This role requires strong leadership and technical skills to manage regulatory submissions, ensuring compliance with cGMP requirements, FDA, OSHA, EPA, and DEA.

Responsibilities
  • Lead the preparation and submission of regulatory documents, including ANDA and NDA.
  • Train and mentor Regulatory Associates to ensure high-quality work.
  • Collaborate with R&D, QC, and Production Managers to achieve project goals.
  • Assist associates, coordinators, analysts, auditors, and specialists as needed.
Requirements
  • Bachelor's Degree in Pharmacy, Chemistry, or Scientific Discipline preferred.
  • Minimum 5 years' experience in Pharma, with at least 2-3 years in technical writing.
  • Strong communication and problem-solving skills.
  • Proficient in Adobe PDF, Microsoft Office, XML, eCTD tools, and advanced computer skills.
Salary

$90,000 - $110,000 per year, depending on experience.



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