Parexel Hiring Regulatory Affairs Consultant – Remote

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.

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.
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
More Jobs
Sarkari Jobs

Leave a Comment