Regulatory Affairs B Pharma & M Pharma Job @ Genpact – Apply
Genpact B Pharma and M Pharma job opening 2022. Pharma job opening 2022. Pharma job opening 2022. Genpact job opening 2022. Regulatory affairs job opening 2022. Lead Consultant job opening 2022. Lead Consultant vacancy, Pharma job opening 2022. M Pharma job 2022. Intrested and eligible candidates may check pout all the details on the same below:
Job Title: Lead Consultant – Reg. Affairs-LIF007773
Primary Location India-Mumbai
Schedule Full-time
Minimum Qualifications
• B. Pham/M.Pharm/Science Graduate
• In-depth working knowledge of ECTD/CTD/NEES/Paper types of submission and industry-standard publishing systems.
• Effective time management and organizational skills
• Effectively communication
• Flexibility to adapt to a changing environment
• Have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, Docubridge, etc.
Preferred Qualifications
• Proven rich experience in Pharmacy Regulatory Affairs
The Role demands an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated & process-driven environment.
Responsibilities
• Publishing and performing technical validation (eCTD/CTD/NeeS/Paper) for the Asia Pacific region and US Submissions.
• Performing final technical quality review.
• Dispatching submission to the relevant authority ((eCTD/CTD/NeeS/Paper) or affiliate so that affiliate
can dispatch to authority;• 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;
• Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments, and metadata.
• Co-ordinate with client/stakeholders
• Project Management skills
Apply Online
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