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
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
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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