Genpact Pharma Regulatory Affairs Job – Candidates Apply Online
Genpact Hiring Pharma Lead consultant vacancy. Regulatory affairs job opening 2022. Pharmacy job opening 2022, M Pharma job opening 2022. B Pharma regulatory affairs job opening 2022, Intrested and eligible candidates may check out all the details on the same below:
Job Title: Lead consultant – Regulatory Affairs-LIF006009
Eligibility Criteria: Graduate in Pharmacy/Science
Skills:
- Good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, Docubridge, eCTD Manager, etc.
- In-depth working knowledge of industry-standard publishing systems and desktop applications.
- Expertise with Publisher applications
- Effective communication, time management, and organizational skills.
- Troubleshooting
- Flexibility to adapt to a changing environment,
- Demonstrated project management and leadership skills.
- Skilled at fostering customer relationships and driving collaboration.
- Understanding of global regulatory processes and requirements.
- Strong attention to detail, and ability to multi-task.
- Expertise with the industry-standard electronic document management system
Publishing and/or related Regulatory/Pharmaceutical area
Preferred qualifications
Postgraduate in Pharmacy/Science
The Role demands for an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated & process-driven environment
Responsibilities
- Publishing and performing final technical quality review and technical validation (eCTD) for Canada submissions.
- Knowledge of IND, DMF, NDA, and BLA submissions. E, g Safety Submissions, Annual reports, OPDP submissions, Protocol and amendment, Original application.
- Notifying relevant stakeholders that the Submission is ready for approval
- Dispatching submission to Canada FDA through ESG.
- Performing post-submission processing activities such as receiving acknowledgment from the authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders;
- Monitoring and reporting submissions activity, such as reporting volume, timelines, and quality metrics; informing future planning and forecasting activities; supporting overall regulatory intelligence.
Apply Online
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