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Regulatory Affairs Generalist

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Parexel

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Contract Type:
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Salary:

Not provided

Job Description:

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.

Job Responsibility:

  • Support global and/or local regulatory teams with comprehensive understanding of regional and global regulatory requirements
  • Manage post-authorization lifecycle maintenance procedures (variations, renewals, PSURs) for multiple licenses
  • Coordinate health authority interactions and responses to questions
  • Prepare and organize local-specific documentation (Module 1) to meet national submission requirements
  • Maintain up-to-date local national systems according to local legislation
  • Manage impact assessments for technical changes affecting marketing authorizations
  • Stay current on regulatory requirements and guidelines to ensure compliance
  • Support health authority inspections as needed
  • Provide technical and business consulting services within area of expertise
  • Complete activities within project scope, timeline, and objectives

Requirements:

  • University Degree in a Scientific or Technical Discipline
  • A few years of experience in an industry-related environment
  • Experience in regulatory authority-facing roles
  • Regulatory Operations (Submission management) experience
  • Experience using Veeva Vault RIMS - strong plus
  • Outstanding interpersonal and intercultural communication skills (written and verbal)
  • Critical thinking and problem-solving abilities
  • Fluent in English, written and spoken
What we offer:
  • Flexible work arrangements
  • Opportunities for career growth
  • Supportive and inclusive environment
  • Diverse and global client exposure
  • Learn from experts

Additional Information:

Job Posted:
January 09, 2026

Work Type:
Remote work
Job Link Share:

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