Parexel is a leading global provider of clinical research and regulatory consulting services. With a mission to improve the world’s health, the company specializes in clinical trials, regulatory affairs, consulting, and market access solutions. Every service offered by Parexel is backed by a deep commitment to quality, patient safety, and innovation. By working at Parexel, professionals contribute to the development of life-changing therapies that benefit patients worldwide.
Job Responsibilities
As a Regulatory Affairs Consultant at Parexel, you will be responsible for the following:
- Managing regulatory affairs related to medicinal product changes that impact product information, particularly in safety and labeling changes.
- Handling Company Core Data Sheet (CCDS) creation or updates to ensure compliance with regulatory standards.
- Conducting change control assessments for various regulatory projects.
- Overseeing safety labeling changes with implications on product information, including the management of AW updates from a regulatory affairs perspective.
- Working on Centralized products, which is considered an advantage.
- Utilizing Veeva RIMS software for regulatory data management.
- Gaining additional knowledge in using the TVT Tool, which is beneficial for the role.
Qualifications Required
To be eligible for this position, candidates must meet the following requirements:
- Minimum 5 years of experience in Regulatory Affairs within EU, UK, CH, AU, or NZ regulatory frameworks.
- Proven expertise in safety labeling changes and their impact on product information.
- Prior experience in CCDS creation or updates is highly preferable.
- Understanding of change control processes and regulatory assessments.
- Familiarity with Centralized product regulations is an added advantage.
- Experience working with Veeva RIMS software.
- Knowledge of TVT Tool is a plus.
Required Skills
- Strong understanding of global regulatory requirements for medicinal products.
- Expertise in safety labeling changes and CCDS updates.
- Proficiency in using regulatory software tools like Veeva RIMS.
- Excellent analytical and decision-making skills.
- Strong written and verbal communication skills.
- Ability to work in a remote environment and collaborate with cross-functional teams.
- Detail-oriented with a commitment to regulatory compliance.
