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Parexel Hiring Regulatory Affairs Consultant – Remote

Parexel Hiring Regulatory Affairs Consultant
Parexel Hiring Regulatory Affairs Consultant

About Parexel

Parexel specializes in clinical trials, regulatory affairs, and market access solutions, driving life-changing therapies that benefit patients globally. The company is committed to quality, patient safety, and innovation, offering a dynamic and supportive work environment. Parexel Hiring Regulatory Affairs Consultant

Job Role: Regulatory Affairs Consultant

As a Regulatory Affairs Consultant, you will be responsible for managing medicinal product changes affecting safety and labeling while ensuring compliance with global regulatory standards. Parexel Hiring Regulatory Affairs Consultant

Key Responsibilities

  • Regulatory Management: Handle medicinal product changes, focusing on safety and labeling updates.
  • Company Core Data Sheet (CCDS) Updates: Create and maintain CCDS to align with regulatory standards.
  • Change Control Assessments: Evaluate regulatory projects for compliance and risk.
  • Safety Labeling: Oversee safety labeling changes and Artwork (AW) updates.
  • Regulatory Software: Utilize Veeva RIMS for regulatory data management.
  • Centralized Product Regulations: Work on Centralized products, gaining EU regulatory expertise.
  • TVT Tool: Apply knowledge of TVT Tool, beneficial for regulatory compliance.

Required Qualifications

  • Education: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, or any Life Sciences degree.
  • Experience: 5+ years in Regulatory Affairs for EU, UK, CH, AU, or NZ regulatory frameworks.
  • Safety Labeling Expertise: Proven track record in safety labeling changes and CCDS updates.
  • Change Control Knowledge: Strong understanding of change control assessments and regulatory impact.
  • Regulatory Software Skills: Experience with Veeva RIMS; knowledge of TVT Tool is a plus.
  • Centralized Products Experience: Prior work in Centralized regulatory submissions is advantageous.
Parexel Hiring Regulatory Affairs Consultant
Parexel Hiring Regulatory Affairs Consultant

Essential Skills

  • Regulatory Compliance: Strong knowledge of global regulatory requirements for medicinal products.
  • Analytical & Decision-Making: Ability to assess regulatory risks and compliance requirements.
  • Software Proficiency: Hands-on experience with Veeva RIMS and other regulatory tools.
  • Communication & Documentation: Excellent written and verbal communication skills.
  • Remote Collaboration: Ability to work independently and collaborate with global teams.
  • Detail-Oriented: Commitment to precision and accuracy in regulatory documentation.
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Why Join Parexel?

  • Remote Work Flexibility
  • Work-Life Balance & Career Growth
  • Challenging Projects in Global Regulatory Affairs
  • Insurance & Employee Benefits

How to Apply?

This is a verified job with an online application process. If you meet the qualifications, apply today and take your career to the next level! Parexel Hiring Regulatory Affairs Consultant

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Parexel Hiring Regulatory Affairs Consultant
Parexel Hiring Regulatory Affairs Consultant
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