Job title: Pharmacy Regulatory Affairs Publisher
Job description: Job Title: Pharmacy Regulatory Affairs Publisher
Position Type: 11+ Months
Vertical- Life Sciences
Job Description Th
- 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
- B. Pham/M.Pharm/Science Graduate
- In-depth working knowledge of ECTD/CTD/NEES/Paper types of submission, industry-standard publishing systems.
- Veeva Vault Experience
- 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.
- Proven rich experience in Pharmacy Regulatory Affairs
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Location: New York City, NY
Job date: Tue, 21 Nov 2023 08:36:09 GMT
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