Genpact Pharma Regulatory Lead Associate Job – Apply Online
With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. Now, we’re calling all you rule-breakers and risk-takers who see the world differently and are bold enough to reinvent it. Transformation happens here. Come, be a part of our exciting journey!
Are you the one we are looking for? Inviting applications for the role of Management Trainee, Publisher!
Job Title: Lead Associate – Regulatory Affairs-LIF006071
Eligibility Criteria:
• B. Pham/M.Pharm/Science Graduate
• In-depth working knowledge of ECTD/CTD/NEES/Paper types of submission, 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
Responsibilities
• Publishing and performing technical validation (eCTD/CTD/NeeS/Paper) for the Asia Pacific region and Europe 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.
Editors Note: Genpact Pharma Regulatory Lead Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
