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Pharmacy Regulatory Affairs Publisher

New York, NY
Job Title: Pharmacy Regulatory Affairs Publisher
Position Type: 11+ Months
Location: Remote
Vertical- Life Sciences


Job Description The 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



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

rahul@reqroute.com
http://reqroute.catsone.com/careers/index.php (Click to see MOST Current Openings)


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ReqRoute, Inc is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, disability, military status, national origin or any other characteristic protected under federal, state, or applicable local law. (www.reqroute.com)

 

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