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Associate- I Reg CMC


Location

India | India


Job description

Job Description

· Preferred Education:

Bachelors or Master (Biotechnology/ Pharmacy/ Science) or Ph. D (Biotechnology/Biological Sciences)

· Preferred Experience:

Minimum 3 Years of experience in Pharmaceutical Industry with major experience in Regulatory Sciences group handling new submissions and / or LCM submission to global health authorities especially USFDA, EMA and other EU authorities. Has an understanding on global strategy and legislation that pertains to Biologics and Biosimilars. Experience in filing Sterile injectable submission is preferable.

· Preferred Attributes:

Good oral and written English communication skills. Good conceptual, analytical, problem solving, and organizational skills. An assertive, take-charge, proven manager with a strong result orientation, positive “can do” attitude, and a sense of urgency to get things done. Can makes decisions to resolve moderately complex problems in standard situations. Makes decisions within guidelines, policies & procedures. Can work independently in ambiguous situations as part of a work team.

· Technical Skills: Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs#LI-PFE


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