Senior Analyst, GBS GRA
Apotex Inc.
full-time
Posted on:
Location Type: Office
Location: Mumbai • India
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Job Level
About the role
- Support in preparation of new product submissions and responsible for product life-cycle management of Apotex products in US and Canada markets
- Preparation of submission and approval notifications for applications submitted to Regulatory agencies
- Responsible for the preparation and review of quality regulatory PLCM submissions for various markets to ensure timely approval
- Support in preparation of NPD submission for various markets to ensure timely approval
- Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance
- Communicate with external sources such as agents and suppliers to request and/or provide data relevant to submissions
Requirements
- A Post-graduate/Graduate degree in Chemistry/Pharmacy/Life Sciences
- Knowledge about pre and post-approval change submission requirement and compilation of new dossier/variation packages for US/CAN/EU/AUS-NZ markets
- Minimum 1 years of experience in US/CAN/EU/AUS-NZ markets
Benefits
- Health insurance
- Professional development
- Flexible work arrangements
- Accommodation for applicants with disabilities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
product life-cycle managementregulatory submissionsquality regulatory submissionsregulatory compliancepre and post-approval change submissiondossier compilationvariation packages
Soft Skills
communicationcollaboration
Certifications
Post-graduate degreeGraduate degree