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: Assistant Manager
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Job Description
RESPONSIBILITIES:
Ensure timely submission of dossiers in US and Canada.
Ensure timely submission of post-approval maintenance activities such as annual reports, labelling and CMC changes, supplements etc.
Thorough evaluation of proposed changes.
Pharmacoepial updations.
Compliance to dossier commitments.
Regular tracking of innovator labeling updations
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TECHNICAL EXPERIENCE:
Thorough knowledge of CMC requirements, labelling requirements, regulatory impact of post approval changes and regulatory life cycle management.
PERSONAL ATTRIBUTES:
Commitment, ownership, integrity, adherence to time lines.
Ability to work with tight time lines.
Good communication skills.
Proactive problem solving.
Additional Information:
Experience: 5-7 yrs
Location: Gurgaon
Qualification: M.Pharma in Pharmaceutics/ Pharmaceutical Chemistry/ Regulatory affairs
Functional Area: R&D
Industry Type: Pharma/ Biotech/Clinical Research
End Date: 31st Jan, 2014
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