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Fresenius Kabi Oncology Limited Job : Pharma Candidates Apply Online for Sr. Research Scientist

Fresenius Kabi Oncology Limited is a public company primarily operating in the field of Research & Development and manufacturing of world-class oncology drugs.

Job Title  – Sr. Research Scientist

Department  – Regulatory Affairs

Educational Qualification  – M.Pharma in Pharmaceutics/Pharmaceutical Chemistry/Regulatory affairs

Experience  – 3-4 years of experience in Regulatory submission for US market

Location –  Gurgaon

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.

Click here to Apply Online

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