Regulatory Affairs Specialist
4 weeks ago
About the Role:
Parexel is seeking a highly skilled Regulatory Affairs Associate to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with labeling regulations and guidelines.
Key Responsibilities:
- Develop and maintain a strong understanding of key labeling regulations and guidelines, including CCDS and USPI.
- Collaborate with cross-functional teams to ensure accurate and compliant labeling.
- Manage the review and approval of labeling documents in a document management system.
- Coordinate artwork approval processes to meet packaging design and legislation requirements.
- Monitor and control artwork changes to ensure compliance.
Requirements:
- 4+ years of experience in drug development, particularly in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
- Strong understanding of SPL and electronic document management systems.
- Ability to research and create comparator labeling documents.
- Excellent communication and collaboration skills.
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Chandigarh, Chandigarh, India Chitkara University Full timeChitkara University is seeking a qualified professional for the role of Assistant & Associate Professor in the Chitkara School of Pharmacy. As a leading institution in Himachal Pradesh, we offer a dynamic and research-oriented environment for academic growth and development. Our college has been ranked 19th for Pharmacy by NIRF 2024, and we strive to...
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chandigarh, India Chitkara University Full timeChitkara University is looking for Assistant & Associate Professor in Chitkara School of Pharmacy at Chitkara University Himachal Pradesh. Chitkara College of Pharmacy has been ranked 19th for Pharmacy by NIRF 2024. The College offers full-time courses in the areas of Pharmacy, which include B. Pharm, Pharm.D., Phar.D. (Post Baccalaureate), M Pharmacy and...
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Assistant Professor- Chitkara College of Pharmacy
3 months ago
Chandigarh, India Chitkara University Full timeChitkara University is looking for Assistant & Associate Professor in Chitkara School of Pharmacy at Chitkara University Himachal Pradesh. Chitkara College of Pharmacy has been ranked 19th for Pharmacy by NIRF 2024. The College offers full-time courses in the areas of Pharmacy, which include B. Pharm, Pharm.D., Phar.D. (Post Baccalaureate), M Pharmacy and...
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2 months ago
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