Regulatory Affairs Specialist II
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Regulatory Affairs Specialist II
Ref No.: 16-02427
Location: Cambridge, Massachusetts
Start Date / End Date: 09/26/2016 to 12/31/2016
Using eCTD Manager or sCubed or Insight applications, this position will be responsible for managing publishing tasks associated with the compilation and dispatch of NDA, BLA, and IND type submissions as well as all associated regulatory transactions to North American Regulatory Agencies.
Publishing responsiblilities include Modules 1 through 5 and all associated regulatory transactions to FDA such as ESG Gateway.
This position will maintain effective interactions with Regulatory Clients to ensure priority conflicts and deviations from the plan are resolved to minimize impact on submission dates and ensure on-time submissions. This position will be responsible for the coordination of publishing tasks associated with the assigned submission, including initial quality control of submissions generated by other Global Publishers.
Skills:Four years’ experience in submission publishing using eCTD Manager, sCubed or similar eCTD building tools. This position will be responsible for managing publishing tasks associated with the compilation and dispatch of NDA, BLA and IND type submissions as well as all associated regulatory transactions to North American Regulatory Agencies.

Thorough knowledge of the content and organization of regulatory submissions required.
Experienced with regulatory submissions publishing and electronic review aids and understanding of application of technologies

Experienced in use of DMS, MS Office tools, ISI Toolbox, and eCTD build tools

Demonstrated regulatory knowledge and awareness, technical competence, sound judgment, and a professional demeanor

Demonstrated leadership and flexibility in dealing with change and diversity

All candidates should have an understanding of the concepts around regulatory affairs and significant knowledge of submissions processes. Thorough knowledge of U.S. FDA Regulations and ICH Guidance’s as they apply to the creation of investigational drug (IND and IDE) and marketing (NDA, BLA, and Device) applications.

Demonstrated ability to work in a technical environment required.
Strong communication and organizational skills required. Task planning and coordination skills required. Ability to multi-task, work well under pressure and time constraints is essential.


Education:Experience utilizing eCTD Manager.
Experience utilizing Insight Publishering Suite.
Experience using sCubed.
Experience in publishing MS Word documents.
Languages:English Read Write Speak

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