A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Freshers in Research
Job Description:
Support 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.
Candidate Profile:
MSc, M.Pharm, Ph.D. Fresh (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or upto 2 years experience
Additional Information:
Experience: 0-2 years
Location: Hyderabad / Secunderabad
Education: M.Pharm, M.Sc, Ph.D
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Development & Medical
Job Type: Full Time
Employment Type: Permanent
Job ID: 78051BR
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