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Manager - Regulatory Operations

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Raritan, NJ
$85,000 - $105,000
Job Type
Direct Hire
Jan 09, 2017
Job ID
Our client - a growing Pharmaceutical company in Raritan, NJ is looking for a  Manager - Regulatory Operations.

The Manager - Regulatory Operations will be responsible for development and implementation of procedures and systems to support Regulatory Submissions and Regulatory Publishing.

The Manager will also be responsible for the establishment and maintenance of an archiving/document management systems and tools (e.g. eDMS, Regulatory Information System, CTD templates, etc.).

The Manager will have overall oversight of submission compilation and publishing support.

The Qualified Candidate will have extensive knowledge with regards to CTD/eCTD structure and requirements as well as having a strong understanding of submission requirements for US submission types (i.e. IND, NDA, PAS, PSUR, etc.)

Unless noted above, applicants MUST be authorized to work in the US without Visa Sponsorship. US citizens and Green Card holders ONLY. We do not provide relocation assistance for those living outside the continental US. Please only click apply if you meet the specific requirements of the job listing, you are able to work in the location listed, and are comfortable with the salary range indicated above. Thanks for your interest. We look forward to working with you.