Working at Cargill is an opportunity to thrive—a place to develop your career to the fullest while engaging in meaningful work that makes a positive impact around the globe. You will be proud to work for a company with a strong history of ethics and a purpose of nourishing people. We offer a diverse, supportive environment where you will grow personally and professionally as you learn from some of the most talented people in your field. With 150 years of experience Cargill provides food, agriculture, financial and industrial products and services to the world. We have 150,000 employees in 70 countries who are committed to feeding the world in a responsible way, reducing environmental impact and improving the communities where we live and work.
Post : MANAGER - REGULATORY AFFAIRS
Job Description
Responsible for applying thorough knowledge of regulatory affairs across a sub-set of a Business Unit.
Understands regulations and assess short-term impacts within scope of responsibility. Assess the risk and opportunities related to regulations, understands & communicates changes.
Accountable for implementing programs, processes and documentation related to regulatory affairs and compliance.
Uses thorough knowledge of regulatory affairs to provide consultation on regulatory topics.
Principal Accountabilities
• Responsible & act as primary accountable lead for new product/ existing product filings 20%
• Responsible & accountable for maintaining applicable regulatory compliance of Internal Manufacturing facilities, Warehouses & External Manufacturers along with trade products 15%
• Regulatory notification and related complaint management with internal / EM teams. Action plan and follow-up till satisfactory closure. 20%
• Plant periodical reviews / audit based on the regulatory/Quality checklist. Ensure action plan is arrived at in co-ordination with Quality team and gaps are addressed to satisfactory closure 10%
• Responsible & accountable to Follow-up, manage CTS, Manufacturing licences, renewal certificates from respective authorities 25%
• Guide, Review and Approve all changes, act as authorized signatory, maintain necessary transparent communications as required 10%
Candidate Profile
• B.Pharm/M.Pharm
• 7-8 years experience in Formulations
• Thorough regulatory knowledge
• QMS documentation, Change management, Risk / Impact assessment
• Data Integrity and traceability review
Preferred Qualifications
• Master’s in Chemistry
Additional Information
Experience : 7-8 years
Qualification : B.Pharm, M.Pharm
Location : Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 15th June, 2018
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