08/05 Apeksha
Senior Executive at Teva Pharma

Views:149 Applications:3 Rec. Actions:Recruiter Actions:0

Regulatory Affairs Associate - Pharma (8-13 yrs)

Anywhere in India/Multiple Locations Job Code: 21770

Education Preferred: Master's degree in a scientific discipline, preferably in life sciences. M.Pharm and/or MS in RA is a plus.

Work Experience: 8 to 10 years in the pharmaceutical industry in 6+ years in Regulatory Affairs (CMC) with a strong background in the generic pharmaceutical industry. Experience of regulatory submissions and deficiency responses to US FDA a distinct advantage.

Specialized or Technical Knowledge:

- Knowledge and experience in Topicals and Complex drug products preferred with a distinct advantage

- RAC certification beneficial but not required


- Demonstrates competency in the business English written skills such as spelling, grammar and punctuation

- Demonstrates good verbal and written communication skills - communicates clearly and concisely

- Demonstrates proficiency with business and scientific software applications and electronic document systems

- Demonstrates good organization skills and the ability to multi-task; detail oriented

- Demonstrates the ability to establish and maintain good working relationships across cross functional groups

- Demonstrates an understanding of ICH and US FDA guidelines and regulations

- Demonstrates the ability to coordinate submissions independently in a time intensive situation

- Demonstrates the ability to provide regulatory assessment and filing categories for post approval changes

- Demonstrates the ability to participate and share information and suggestions with management, peers and others

- Demonstrates good critical and logical thinking. Able to analyze problems, identify solutions and implement recommendations

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

Add a note
Something suspicious? Report this job posting.