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
- 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.
- Thorough knowledge of CMC requirements, labelling requirements, regulatory impact of post approval changes and regulatory life cycle management.
- Commitment, ownership, integrity, adherence to time lines.
- Ability to work with tight time lines.
- Good communication skills.
- Proactive problem solving.