Officer Jobs at Lupin | Chemistry Candidates | Apply Now
Are you looking for Officer Jobs in a leading pharmaceutical company? Lupin Careers offers a fantastic opportunity for professionals with a Master’s or a graduation in Pharmacy or Science to join their Regulatory Affairs team. This role involves handling submissions, post-approval activities, and providing regulatory support for markets including Europe, Australia, New Zealand, and Canada. Explore Lupin Jobs today and take your career to the next level.
About Lupin:
Lupin is a global pharmaceutical company committed to delivering high-quality medicines across the world. With a focus on innovation, customer satisfaction, and talent development, Lupin Careers provides opportunities for professionals to grow in a dynamic and collaborative environment.
- Location: Airoli, MH, IN
- Company: Lupin
Job Description
Responsible for submissions of Response to Deficiencies to Health Agencies of Europe, Australia, New Zealand, and Canada market and Customers. Responsible for post approval submissions to Europe, Australia, New Zealand, and Canada markets. To provide Regulatory inputs during inspections by Regulatory authorities and customers as and when required. To provide Regulatory inputs during product development, manufacturing, and testing, and to evaluate all types of change proposals during the product life cycle.
Education
- Masters
- Graduation in Pharmacy or Science
Work Experience
- Should have worked in the Regulatory Affairs Dept for regulated markets like EU/UK, Australia, Canada, US, etc. (minimum 1-2 years).
- Submission of new submissions, deficiency responses, and/or post-approval submissions for the above markets.
- Worked on various dosage forms, including complex generics.
- Compilation of Module 2 and 3 CTD sections for the above submissions. Review of documents for all these sections.
- Knowledge of ICH as well as country-specific guidance for documents to be submitted in all the above sections.
- Hands-on experience for ECTD compilation.
Competencies
- Strategic Agility
- Process Excellence
- Collaboration
- Innovation & Creativity
- Result Orientation
- Stakeholder Management
- Customer Centricity
- Developing Talent
