Position: Regulatory Affairs Associate – Labelling
Company: Parexel International
Location: Remote (India)
Experience Required: 3-5 years in Regulatory Affairs (Labelling & Safety Changes)
Posted: Recently
About Parexel
Parexel is a leading global clinical research organization (CRO) and regulatory consulting firm, supporting biopharmaceutical and medical device companies in bringing innovative therapies to market. With expertise across multiple therapeutic areas, Parexel ensures compliance with international regulatory standards, helping clients navigate complex approval processes.
Key Responsibilities
As a Regulatory Affairs Associate – Labelling, you will:
- Manage safety and labelling changes impacting Product Information (PI).
- Handle Company Core Data Sheet (CCDS) creation and updates for regulatory compliance.
- Conduct Change Control Assessments for regulatory submissions.
- Support Agency Workflows (AW) updates from a Regulatory Affairs (RA) perspective.
- Utilize Veeva RIMS (Regulatory Information Management System) for documentation and submissions.
- Oversee Centralized Products (EU/UK/CH/AU/NZ) to ensure compliance with global labelling regulations.
- Work with TVT Tools for regulatory tracking and documentation.
Qualifications & Experience
Education:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or related fields.
Experience:
- 3-5 years in Regulatory Affairs (Labelling & Safety Changes).
- Strong knowledge of EU/UK/CH/AU/NZ regulatory frameworks.
Technical Skills:
- Experience with CCDS updates & regulatory submissions.
- Hands-on expertise in Veeva RIMS.
- Familiarity with TVT tools is a plus.
- Understanding of centralized regulatory processes.
Soft Skills:
- Strong communication, analytical, and problem-solving abilities.
- Ability to work independently in a remote setting.
