Regulatory document specialist ii - united states, boston

position: regulatory document specialist ii
location: remote (boston, ma)
duration: 7+ months(possible extension)
 
alternate title: regulatory operations publishing manager
position summary: the regulatory document specialist ii, submission operations, is accountable for managing the routine and non-routine submission activity for client's portfolio.  the regulatory document specialist ii, submission operation, in collaboration with the regulatory lead, designs and executes high quality global submission plans, ensuring client delivers compliant submissions to global health authorities within required timeframes. the regulatory document specialist ii submission operations provides technical expertise to cross-functional submission project teams, to promote and bring excellence in planning, preparation, and delivery of regulatory submissions, and will act as the primary point of contact for project and/or submission teams when significant planning effort and oversight is required.  it is expected that regulatory document specialist ii submission operations, will be significantly involved in publishing activities and will also contribute to archiving activities of the group. 
education: a minimum of a bachelor's degree in a scientific or technical discipline is required; equivalent experience may be accepted. a minimum of 4 years pharmaceutical or other related industry experience with 1-3 years of regulatory submission management experience 
languages:
english( speak, read, write )
 
skills: prior publishing and archiving experience is highly desirable and preferred submission management very knowledgeable in ctd/ectd structure and requirements and a good understanding of submission requirements for global submission types (e.g. ind, bla, maa, nds, cta, psur etc.). must be able to adhere to strict project timelines, and to advise teams and management of impacts and changes in project timelines.

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