Regulatory Affairs Specialist
Job Type Full Time
Experience 5 years
Job Field Pharmaceutical
The Regulatory Affairs Pharmacist is responsible for assisting the Regulatory Affairs Manager with the end to end cycle of product registration across the Sub Saharan Africa. The Regulatory Affairs Pharmacist is a self-driven individual to manage the therapeutic portfolios assigned to relevant countries, in every aspect of new product submission, product registration and life-cycle management by ensuring high quality, timeous submissions, responses and approvals. He/ she will conduct and complete technical and administrative duties on dossiers.
- Provide Regulatory intelligence
- Ensure pre-launch statge product submission and registration activities
- Ensure dosier life cycle management registration activities
- Support and enable delivery for the Cipla India SSA, CGA and CiplaQCiL team
- Develop and manage stakeholder relationships
- Ensure execution of all regulatory Activities
- Cross functional integration support
- Bachelor in Pharmacy, Post graduate qualifications are an added advantage
- 5 years’ experience in the pharmaceutical industry. Experience in regulatory affairs, manufacturing and managing others desirable
MODE OF APPLICATION
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Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. For over 80 years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Our portfolio includes over 1000 products across wide range of therapeutic categories with one quality standard globally. Whilst delivering a long-term sustainable business, Cipla recognises its duty to provide affordable medicines. Cipla’s emphasis on access for patients was recognised globally for the pioneering role played in HIV/AIDS treatment as the first pharmaceutical company to provide a triple combination anti-retroviral (ARV) in Africa at less than a dollar a day and thereby treating many millions of patients since 2001. Cipla's research and development focuses on developing innovative products and drug delivery systems.