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: 30th September, 2014
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