Job Description

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 requiredSkills/Competencies:- 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 (ref:biojoby.com)

www.biojoby.com