Genpact Walk-in Interview 2022 B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy for Lead Consultant, Pharma Regulatory Affairs At Mumbai. Genpact Notification full details below.Interested and eligible candidates Apply Online.
- Vacancy details:
- Post Name: Lead Consultant, Pharma Regulatory Affairs
- Qualification: B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy
Job Description: Genpact Hiring For Lead Consultant, Pharma Regulatory Affairs !Inviting applications for the role of Lead Consultant, Pharma Regulatory Affairs
- Important Details :
- Location: Mumbai
- Post of date:12/03/2022
- Selection Process: The selection will be on the basis of Interview.
- Minimum qualifications/skills
- B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy
- Excellent Verbal and Written communication skills
- Ability to transfer knowledge
- Ability to engage with people immediately & build Relationship
- Team Management skills and proficiency
- Good client communication
- Basic project management skills
- Mentoring junior team members
· 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
Qualifications we seek in you!
• Good at problem-solving & Decision Making
• Enthusiasm & confidence
• Adhere to our principles and values
• Time Management skills
• Organizational Skills
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.