Genpact Pharma Technical Associate Vacancy – Apply Online
Genpact hiring a regulatory affairs manager. Manager job opening 2023, Pharma job opening 2023, B Pharma job opening 2023, Pharma job opening 2023, Regulatory affairs job opening 2023. Intrested and eligible candidates may check out all the details
Job Title: Technical Associate – Reg. Affairs-LIF011581
Primary Location India-Mumbai
Qualifications we seek in you!
- B. Pham/M.Pharm/Science Graduate
- In depth working knowledge of ECTD types of submission, industry standard publishing systems.
- Effective time management and organizational skills
- Effectively communication
- Flexibility to adapt to a changing environment
- Good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, Docubridge, etc.
Experience in Pharmacy Regulatory Affairs
The Role demands an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated & process-driven environment.
- Publishing and performing technical validation (eCTD/CTD/NeeS/Paper) for the LATAM and Canadian 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 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.
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