Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Post: Reg Affairs Officer 1-1501974
Job Description:
1. Primary Masters degree in Pharmacy, biotechnology, chemistry or life science.
2. 3-5 years CMC regulatory affairs experience with in-depth knowledge and experience of regulations and requirements for Life Cycle Management of various types of products (variations, labeling updates, MA transfers, Module 3 prepration, SmPC, renewals)
3. Demonstrated strong writing and communication Skills
4. Strong attention to detail, ability to multi-task
• Liaises with internal (onsite and global) or client staff to obtain documents for use in authoring global post-approval CMC submissions and LCM activities
• Plans and authors regulatory submissions using a client template, Quintiles templates, or using the clients IT systems/platform
• Submissions include: Module 3, Module 2.3, variations, new BLAs for EU, US & ROW markets
• Attends internal meetings as necessary to support submission authoring projects
• Serve on global projects supporting clients in drug development and discovery for various therapeutic areas
Candidate Profile
Bachelors Degree, with 4 yrs relevant exp in Regulatory.
Additional Information:
Experience: 4 year
Location: India
Job Id: 1501974
Last Date: 25th June, 2015
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