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

Skills/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

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