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Cipla Limited is an Indian multinational pharmaceutical and biotechnology company, headquartered in Mumbai, India. Cipla primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control and depression; other medical conditions.
About the job
Job Purpose
Support the Regulatory Affairs function in its pre-registration and/or post-registration dossier submission activities by assisting in data gathering, screening, collating and compiling of the dossiers, post-registration variations and any other documentation in order to submit the same to the Health Authorities for approval within the defined timelines as per overall objective of Cipla Medpro.
Accountabilities
CDT/New dossier submissions and approvals
Perform pre-launch activities to ensure timeous submission and registration of products within the defined timelines.
Dossier Life Cycle Management- Perform the dossier life cycle management activities by supporting the post registration variations and other activities to ensure support to the regulatory function and its objectives
Support and assist the administrative team in the responsibility to effectively manage and maintain dossiers (electronically and hard copies), collection and delivery of documents, ensure smooth operations and maintain quality standards
Develop and manage stakeholder relationships by communicating and interacting on a regular basis in order to achieve the functional objectives
Educational Qualifications
BPharm or BSc. or higher post graduate scientific degree
Relevant Experience
Minimum 2 years of experience in the regulatory function covering all areas, Attention to detail, Resilience, Collaborative approach, time-management, good communication skills, team player; experience in e-CTD submissions
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