Fresenius Kabi Oncology Limited is a public listed company primarily operating in the field of Research & Development and manufacturing of world-class oncology drugs. The company strives to provide most advanced third generation chemotherapeutic drugs right from development to manufacturing & marketing across the globe. It is fast emerging as a leading player in oncology generics on the strength of its comprehensive product portfolio of injectables, oral cytotoxics, cytostatics, intermediates and active pharmaceutical ingredients (APIs).
Post: Sr. Research Scientist
Job Description:
RESPONSIBILITIES:
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Ensure timely submission of dossiers in US and Canada.
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Ensure timely submission of post-approval maintenance activities such as annual reports, labelling and CMC changes, supplements etc.
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Thorough evaluation of proposed changes.
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Pharmacoepial updations.
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Compliance to dossier commitments.
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Regular tracking of innovator labeling updations.
TECHNICAL EXPERIENCE:
- Thorough knowledge of CMC requirements, labelling requirements, regulatory impact of post approval changes and regulatory life cycle management.
PERSONAL ATTRIBUTES:
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Commitment, ownership, integrity, adherence to time lines.
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Ability to work with tight time lines.
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Good communication skills.
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Proactive problem solving.
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Educational Qualification: M.Pharma in Pharmaceutics/Pharmaceutical Chemistry/ Regulatory affairs
Experience: 3-4 years of experience in Regulatory submission for US market
Additional Information:
Experience: 3-4
Location: Gurgaon
Qualification: M. Pharm in Pharmaceutics
Functional Area: R&D
"Industry Type: Pharma/ Biotech/Clinical Research
End Date: 25th Dec, 2013
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