Consultant II

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POST DATE 6/7/2019
END DATE 7/13/2019

SYNER-G PHARMA CONSULTING, LLC SOUTHBOROUGH, MA

Location
SOUTHBOROUGH, MA
AJE Ref #
584222182
Job Classification
Full Time
Job Type
Regular
Company Ref #
REF# 8478.014
Experience
Entry Level (0 - 2 years)
Education
Masters Degree

JOB DESCRIPTION

Provide Regulatory affairs consultancy to clients during the development and post-approval phase of their drugs. Provide scientific advice, Regulatory Affairs Strategies, regulatory requirements advice & implementation. Gather information about specific needs, objectives, functions, features, input and deliverables. Little travel to various unanticipated locations throughout the U.S. to interact with clients and train users for different short-term assignments. Interact with clients remotely regarding regulatory issues and deliverables on regulatory submissions. Manage global teams to ensure quality and timeliness of client deliverables. Conduct regulatory reviews of technical summaries and reports. Prepare regulatory filings for investigational/marketing application. Review technical documents, including analytical reports, validation reports, specification and manufacturing process reports. Ensure compliance to applicable US FDA guidance documents. Prepare and review technical documents of NDA/BLAs, IND applications and Regulatory CMC Responses to the Health authority. Perform CMC regulatory activities of applications for small-molecules and biologics. Perform Regulatory assessment of CMC changes and prepare respective supplements, annual reports to marketing applications. Author submissions to health authorities including INDs and NDAs for review and acceptance of clients drug products by health authorities. Perform gap analysis for said applications. Must have a Masters Degree in Regulatory Affairs and Healthy Policy. Must have three (3) months of experience in the job offered or as a Regulatory Affairs Associate. Three (3) months of aforementioned experience must have included all of the following: 1) Regulatory affairs strategy; 2) CMC Responses; and 3) NDA/IND.