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Saturday, February 12, 2011


Job DescriptionSupport timely preparation of high quality drug substance and/or drug product Quality (CMC) documentation, to support global regulatory submissions

Prepare CMC responses to health authority questions, during development, registration, and product lifecycle

Identify the required documentation for submissions and negotiate the delivery of approved technical source documents in accordance with project timelines

Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects

Support to compliance activities
The major activities would be to :

QC the registration documents according to appropriate checklists

Support the Reg CMC teams in their document management duties

Support the electronic document management and publishing systems

Support the HAQ database management, QC checking of published dossiers

Support the Variation approval tracking, Document Administration check and DRAGON remediation

Write high-quality CMC documentation.
Desired ProfileMSc, M.Pharm, Ph.D. Fresh ((e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or upto 2 years experience
Experience0 - 2 Years
Industry TypePharma/ Biotech/Clinical Research
Functional AreaOther
EducationUG - Any Graduate - Any Specialization
PG - Any PG Course - Any Specialization
LocationHyderabad / Secunderabad
Novartis Healthcare Pvt Ltd 
Website  Click Here


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