Company: Parexel International
Position: Senior Regulatory Affairs Associate (Labelling)
Department: Regulatory Affairs – Labelling
Location: Bengaluru, India (Remote Flexibility)
Experience: 4–6 Years
Category: Consulting
Job ID: R0000035749
Date Posted: 26 September 2025
About Parexel Consulting
Parexel Consulting plays a crucial role in helping biopharmaceutical and medical device companies navigate the complex and evolving global regulatory landscape. By combining scientific, technical, and regulatory expertise, Parexel helps clients develop and implement regulatory strategies that bring their products to market faster and ensure long-term compliance.
The organization values collaboration, innovation, and continuous learning. As a team member, you’ll work with a diverse range of clients, gain exposure to various product types and therapeutic areas, and enhance your skills through challenging assignments and expert mentorship. Additionally, Parexel offers the flexibility of remote work while maintaining a supportive and dynamic team culture.
Key Responsibilities
- Develop and implement regulatory labeling strategies to support global product lifecycle management.
- Coordinate label development including CCDS, USPI, and packaging materials.
- Ensure compliance with US, EU, Switzerland, Canada, and Australia labeling regulations.
- Research and prepare comparator labeling documents and annual regulatory reports.
- Collaborate with Tech Ops for artwork implementation and manage label updates, compliance, and governance.
- Oversee artwork approval processes for printed packaging components, ensuring design and legislation requirements are met.
- Maintain artwork trackers, systems, and ensure the latest PDF versions are available.
- Liaise with internal and external teams to ensure accurate and timely implementation of labeling changes.
- Manage post-approval labeling submissions including PSUR and electronic document management.
- Handle SPL (all types, aspects, and troubleshooting) and ensure accurate labeling review and approvals.
- Support the creation and review of consumer advertising and educational materials.
- Use and manage tools like Veeva, TVT, Docubridge, and other electronic submission platforms.
Required Experience & Skills
- 4–6 years of experience in drug development, labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
- Strong understanding of global labeling regulations and lifecycle management.
- Proficiency in SPL, electronic document management systems, and labeling compliance processes.
- Experience with artwork approval workflows and packaging component changes.
- Familiarity with advertising, promotional, and educational material regulations.
- Hands-on experience with systems like Veeva, TVT, Docubridge.
- Excellent organizational, communication, and cross-functional collaboration skills.
Why Join Parexel?
- Work with a global leader in regulatory affairs and consulting.
- Collaborate with top pharmaceutical and medical device companies worldwide.
- Enjoy remote work flexibility and a supportive, innovative work environment.
- Gain exposure to diverse therapeutic areas and career development opportunities.
Job Overview at a Glance
| Details | Information |
|---|---|
| Company | Parexel International |
| Role | Senior Regulatory Affairs Associate (Labelling) |
| Department | Regulatory Affairs – Labelling |
| Experience | 4–6 Years |
| Location | Bengaluru, India (Remote Flexibility) |
| Category | Consulting |
| Job ID | R0000035749 |
| Date Posted | 26 September 2025 |
How to Apply
Interested candidates can visit the Parexel Careers Portal and apply for Job ID R0000035749 to begin their application process.
