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Lead Consultant - Regulatory Affairs

2.00 to 7.00 Years   Mumbai City   24 Mar, 2023
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

    Assistant Manager, PublisherThe 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 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 Qualifications we seek in you Minimum qualifications 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,

Keyskills :
sapcustomer relationssalesproject management

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