Regulatory Affairs Coordinator

3 weeks ago


Hartford, Connecticut, United States Onsite Personnel LLC Full time
Job Description

At Onsite Personnel LLC, we are seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with cGMP requirements, FDA regulations, and company policies.

Key Responsibilities:
  • Coordinate with cross-functional teams to procure documentation for regulatory submissions.
  • Review technical documents for accuracy and determine their acceptability for use in regulatory submissions (i.e., ANDA and NDA).
  • Create documents in accordance with eCTD specifications.
  • Maintain the internal database as needed.
  • Comply with FDA guidelines and company policies on data integrity.
Requirements:
  • Bachelor's Degree in Pharmacy, Chemistry, or a scientific discipline preferred.
  • At least 1 year of experience with technical writing is preferred.
  • Minimum 3 years of pharma experience is preferred.
  • Proficient in Adobe PDF, Illustrator/In Design, Microsoft Office, and advanced computer skills.
  • Continuous working knowledge of applicable FDA/ICH/DEA regulations.
  • Continuous working knowledge of applicable cGMP guidelines.

We offer a competitive salary range of $60,000 - $80,000 per annum, depending on experience. This position is an excellent opportunity for individuals looking to advance their careers in regulatory affairs.

About Onsite Personnel LLC:

Onsite Personnel LLC is an equal opportunity employer committed to creating an inclusive work environment. We value diversity and do not discriminate based on disability, veteran status, or any other basis protected under federal, state, or local laws.



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