Genpact Released Job Openings On 23/11/2022.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.
Genpact Recruiting B.Pharma,B.Sc,M.Pharma,M.Sc with experience for Lead Consultant, Pharma Regulatory Affairs Position.Complete Details for the Lead Consultant, Pharma Regulatory Affairs as follows.
Important Details :
- Location :Mumbai
- No of Vacancies:Not Disclosed
- Details of Salary:Not Disclosed
- Opening date for online Application: 23/11/2022
- 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
Job Description/Skills Required
- Dossiers preparation in CTD modules & submission
- Post-approval regulations
- Artwork updates- Liaising and coordinating with Labelling teams, supply and Quality. Proactive with Batch launching and delivery updates.
- Responsible for review and update of artwork if required
- Post-approval submission knowledge for EU markets
- Knowledge of manufacturing documents like batch records, specifications, analytical methods, validation reports, stability data.
- Developing and writing clear explanations and justifications for any new change or update in the dossier
- Demonstrating leadership in departmental improvement activities such as system modifications, maintenance of standard operating procedures, internal guidelines etc.
- Demonstrating an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity
- Managing & executing of CMC documentation including variations and responses to health authority questions per established business processes and systems
- Depending on experience level, mentor newly hired staff or lead a team of junior staff.
- Responsible for the preparation and review of the information required for the development of regulatory CMC
- Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems