Excellent Opportunity For B.Pharma,B.Sc,M.Pharma,M.Sc Graduates At Genpact

Genpact Released Job Openings On 18/08/2022.Genpact (NYSE: G) is a global professional services firm focused on delivering digital transformation for our clients, putting digital and data to work to create competitive advantage. We do this by integrating lean principles, design thinking, analytics and digital technologies with our domain and industry expertise to deliver disruptive business outcomes – an approach we call Lean DigitalSM..Eligibility Criteria / Educational Qualification, Official Notification, Apply Online Form Link & Other Relevant Details for Genpact Recruitment 2022 are provided below. Interested and eligible candidates can  submit application along with resume. 

Vacancy Details:

Genpact Recruiting B.Pharma,B.Sc,M.Pharma,M.Sc with experience for Lead Consultant – Regulatory Affairs Position.Complete Details for the Lead Consultant – Regulatory Affairs as follows.

Important Details :

• Location :Mumbai
• No of Vacancies:Not Disclosed
• Details of Salary:Not Disclosed
• Opening date for online Application: 18/08/2022
• Mode of application :Online
  
• How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps

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Job Description/Skills Required

Consumer CMC

• Responsible for implementing CMC regulatory strategies for assigned consumer products in accordance with global regulations, guidances and defined regulatory strategies.
• Responsible for the writing of CMC quality documents for the dossier and/or the entire module 3 from raw data.
• Review and evaluation of existing quality documentation and assessment of required updates during Project Renewals.
• Preparation of Quality Overall Summaries (QOS);
• Compilation of dossiers for launch applications for marketing authorization and new drug applications in Global markets.
• Submission of relevant sections in Annual Reports for US Market.
• Preparing RA expert response for deficiency letters from various regulatory authorities;
• Assessment of registration documentation for consumer products as per the current Health Authority requirements.
• Knowledge of review and assessment of manufacturing, analytical, validation and stability documents.
• Post-approval submission knowledge for EU markets

Additional

• Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission
• Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously
• Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables
• Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations, and takes a new perspective using existing solutions
• Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process.
• Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures
• Depending on experience level, mentor newly hired staff or lead a team of junior staff.
• Flexibility in responding to changing priorities or dealing with unexpected events.
• Capability to handle multiple priorities and balance work to achieve business goals.

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