Senior Manager, Regulatory Affairs / RA
Sterling Life Sciences - Newark, NJ

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1) Assist the VP Regulatory Affairs in coordinating activities in the preparation and submission of the eCTD NDA for all company products
2) Interact with Regulatory Operations Team at external regulatory consulting firm
3) Interface with Project Management Team regarding budgets and timelines for all departmental efforts
4) Represent Regulatory Affairs on Product Development teams
5) Maintain awareness of rules, guidance and regulations that impact the company and develop solutions as required
6) Maintain RA server/intranet, including the filing, tracking, scanning and naming of all electronic files
7) Coordinate regulatory agency meetings and prepare meeting materials
8) Act as FDA liaison for assigned projects
9) Maintain and update IND's and other regulatory documents
10) Prepare RA SOP's
11) Ensure compliance with all post marketing activities

1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the pharmaceuticals industry is strongly preferred
4) Preference will be given to people who have recent experience in Regulatory Affairs Management