About Sun Pharma Industries Limited:
Sun Pharma is the world’s fourth-largest Speciality generic pharmaceutical company and No. 1 in India. We provide high-quality, affordable medicines trusted by customers and patients in over 100 countries.
Sun Pharma’s global presence is supported by more than 40 manufacturing facilities spread across 5 continents, R&D centres across the globe and a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising around 2,000 scientists and R&D investments of over 7-8% of annual revenues.
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About Sun Pharma Industries Limited Jobs Vacancy Details:
Sun Pharmaceutical Inds Ltd, Baroda
Opening in Regulatory Affairs – US group (Labeling)
Experience: 3 – 5 years
Job Description:
1. Original Application submission
ü Labeling development for original applications (NDA/ANDA) in accordance with RLD labeling, current FDA guidance (s) and carve‐outs based on patents and exclusivity claims
2. Labeling Query responses/ REMS and Patent Amendments/ PNP Requests
ü Thorough review/interpretation of FDA comments.
ü Preparation / Review of revised labeling and response.
ü Tracking/ Review for Completeness/ Timely Submission of Amendments
ü Preparation / Review of patent amendment & proprietary name review request
ü Submission of Final Approval Requested
3. Life Cycle Management
ü Track RLD labeling changes
ü Initiate labeling revision activity as per RLD label revision/safety labeling change ﴾SLC﴿ notification from FDA
ü Submission of Labeling Supplements (CBE 0/ CBE 30/ PAS)
ü Timely submission of REMS
ü Review of revised artworks
ü Databases/ artwork repository maintenance
Send your resume to: Rosemary.varghese@sunpharma.com
Freshers need not apply
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FAQ Related to Sun Pharma Industries Limited
Q. What is the rank of Sun Pharma?
Ans: 1
Q. Who is the owner of Sun Pharma?
Ans: Dilip Shanghvi
Q. Which is the official website of Sun Pharma?
Ans: https://sunpharma.com/
