Regulatory Affairs Specialist Job at United Consulting Hub, Colorado

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  • United Consulting Hub
  • Colorado

Job Description

Job Title: Regulatory Affairs Associate (0 2 Years Experience) Location: Remote

Experience: 0 2 Years

Industry: Pharmaceutical / Healthcare / Medical Devices / Life Sciences Job Summary

We are seeking a motivated Regulatory Affairs Associate to support regulatory submissions and ensure compliance with applicable regulatory requirements. The ideal candidate will assist in preparing documentation, coordinating with internal teams, and maintaining regulatory records.

Key Responsibilities
  • Assist in preparing and submitting regulatory documents to health authorities.

  • Support preparation of regulatory submissions such as CTD/eCTD, dossiers, variations, and renewals .

  • Review product labels, packaging materials, and promotional content to ensure regulatory compliance.

  • Maintain regulatory documentation and databases.

  • Track regulatory submission timelines and approvals.

  • Coordinate with R&D, Quality Assurance, Manufacturing, and Marketing teams for regulatory requirements.

  • Monitor regulatory updates and ensure compliance with applicable guidelines.

  • Assist in responding to regulatory authority queries.

Required Qualifications
  • Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, or related field.

  • 0 2 years of experience in Regulatory Affairs (freshers with relevant internships can apply).

  • Basic understanding of regulatory guidelines (FDA, EMA, CDSCO, or other relevant authorities).

  • Good documentation and communication skills.

  • Attention to detail and ability to work with regulatory documentation.

Job Tags

Internship, Remote work

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