Pharmacy Regulatory Affairs Publisher

Job title: Pharmacy Regulatory Affairs Publisher

Company: ReqRoute

Job description: Job Title: Pharmacy Regulatory Affairs Publisher
Position Type: 11+ Months
Location: Remote
Vertical- Life Sciences

Job Description Th

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

Minimum qualifications

• 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.

Preferred Qualifications

• Proven rich experience in Pharmacy Regulatory Affairs

Regards,

Rahul Yadav
(408) 560-3956

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Expected salary:

Location: New York City, NY

Job date: Tue, 21 Nov 2023 08:36:09 GMT