Career as Regulatory Affairs Specialist in PPD Pharmaceuticals

PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 32 countries and more than 9,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients.

Post: Regulatory Affairs Specialist

Qualifications
Required are:

·         Bachelor or higher graduate degree in science-related field.
·         At least 2 years of professional experience within Regulatory
·         Having relevant exposure in handling regulatory requirement for Europe or International market which includes Initial MA, Variations, Renewals & PSURs etc.
·         Sound knowledge of CMC, CTD dossiers and various ICH guidelines.
·         Additional knowledge about labelling, familiarity with globally-deployed regulatory publishing tools, processes and systems will also be an advantage.
·         Very good English language skills
·         Attention to detail and quality of documentation
·         Effective oral and written communication skills
·         Ability to work on own with minimal supervision
·         Suitable experience working in the pharmaceutical/CRO industry is preferred

Additional Information:
Experience: Min. 2 Years
Location: Mumbai
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Job Code: 112491
End Date: 30^th September, 2014

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