Regulatory Affairs Specialist

4 weeks ago

Brownsburg, Indiana, United States Medix Full time
Regulatory Specialist Job Description

Medix Life Sciences is a leading staffing organization specializing in Clinical Research and Life Sciences placements. We are seeking a highly skilled Regulatory Specialist to join our team.

Key Responsibilities:
  • Assist in regulatory submission, annual reports, registrations, and listings to ensure compliance with applicable drug regulations, guidance, and standards.
  • Maintain regulatory files, including INDs and NDAs, and ensure timely renewals, drug listings, site registrations, and supplements for changes.
  • Prepare responses to regulatory authorities' questions within assigned timelines and stay up-to-date with regulatory procedures and changes.
  • Support external regulatory agency audits and provide regulatory input to minimize potential findings of non-compliance.
  • Collaborate with other departments to communicate submission requirements and compile submissions.

Requirements:
  • Bachelor's degree or higher.
  • 2+ years of Regulatory experience, preferably in the pharma, med device, and/or CRO industry.
  • Experience with DMF Maintenance, ANDA, and/or IND Maintenance, Annual Report Data Gathering, and other relevant skills.

Location: Brownsburg, IN 46112
Pay: 35-50/hr depending on experience
Hours: M-F 9am-5pm
Duration: 6 month contract to hire

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