PAREXEL is a leader in biopharmaceutical services, providing essential support to the biotech and pharmaceutical industries in the development of new drugs and treatments globally. They offer knowledge-based contract research, medical communications, and consulting services across various therapeutic areas.
Job Opening: Senior Regulatory Affairs Associate (Labeling)
Location: Remote (India – Bengaluru, Chandigarh, Mohali, Hyderabad, Mumbai)
Job Description:
PAREXEL is seeking a Senior Regulatory Affairs Associate with a strong background in drug development, particularly in labeling, product packaging coordination, and regulatory affairs.
Key Responsibilities:
- Experience Requirements:
- Minimum of 4 years in drug development focusing on labeling, clinical supplies, and regulatory affairs.
- Knowledge of key labeling regulations and past experience in label development (e.g., CCDS, USPI, packaging).
- Labeling Documentation:
- Research and create comparator labeling documents.
- Strong understanding of annual reports and submission processes.
- Collaboration:
- Work with Technical Operations on artwork implementation and management.
- Liaise with internal and external suppliers/departments to ensure smooth implementation.
- Artwork and Packaging Management:
- Coordinate artwork approval for printed packaging to comply with design and legislative requirements.
- Monitor and manage artwork changes and maintain Artwork Trackers & Systems.
- Regulatory Submissions:
- Experience with PSUR submissions, CCDS-related submissions, and safety variations.
- Proficiency in SPL and managing the review/approval of labeling in document management systems.
Technical Skills:
- Proficient in relevant software and systems for labeling management.
- Strong attention to detail and excellent communication skills.
- Ability to handle multiple projects and adapt to changing regulatory environments.
Why Join PAREXEL?
- Contribute to groundbreaking drug and treatment development.
- Collaborate with a dedicated team of professionals.
- Enjoy a flexible work environment with remote options across multiple locations in India.