ronus Pharma is a fast-growing, privately held generic veterinary pharmaceutical company located in New Jersey, dedicated to providing innovative and cost effective products to the animal health market. Our team of seasoned industry professionals have been intimately involved in the establishment, and growth of several pharmaceutical manufacturing, and distribution firms in both the human and animal health pharmaceutical industries.
Walk-ins:
- 6th, 7th JUNE – 2024
- Time: 09:30 AM to 2:00 PM
- LOCATION: Cronus Pharma Specialties India Pvt Ltd, GMR Hyderabad Aviation SEZ, Mamidipally (V), Balapur (M), RR (D),
- More Information © HR- 7337445157/7337445197
- Department: Regulatory Affairs
- Experience: 8 Years to 10 Years
- Qualification : M.Sc / B.Pharm / M.Pharm
Job Description:
• Review technical documents & author dossier (Injectables) in CTD format for US (ANADA).
Assessment, preparation of CMC query responses & coordination skills with CFT.
• Assessment & review of change controls (Injectable facility & CMC) and finalize the reporting category. Post approval life cycle management activities:
• Preparation & review of CMC supplements.
• peparation & review of Annual Reports.
• Provide guidance to R&D team during product development.
• Liaise with US Agent (US office) regarding all submission requirements and regulatory strategy.
• Co-ordinate with internal QC/QA for timely receipt of documents for dossier compilation
• Liaise with R&D Team for any formulation related documentation strategy.
• Mentor and coach Team with current regulatory requirements and be current with all latest guidelines affecting the product submissions.
• Maintain, evaluate, update new software or hardware requirements for submission purposes
• Required Skills, Experience & Qualification:
• Prior knowledge and experience of US regulatory submissions (main requirement) and EU submissions is desired. Knowledge of FDA, CGMP, ICH, DMF guidelines for regulatory submissions
• Hands on experience in labelling revisions, submissions, supplemental applications
• Excellent written and verbal communication skills
• Ability to work independently and handle a Team of four or more.
• Excellent analytical and problem-solving skills.
• Proficient with applicable database and compliance software
• Proficient with Microsoft Office Suite or similar software.
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