FierceBiotech and FiercePharma Jobs
Director of Regulatory Operations - Discovery Solutions LLC Recruiting
Nov 12
Location: Branchburg, NJCategories: Pharmaceutical
Website: http://http://sites.google.com/site/debbiewilmerpharmapostings/
Position Description
The incumbent is responsible for providing supervision, management and leadership for Regulatory Operations in the planning, compilation, and publishing, of regulatory submissions. The Director is also responsible to develop the expertise to assure the quality of the submissions, and adherence to regulatory standards and requirements for electronic and paper submissions.
The candidate works directly with all functional areas that author final reports, and sections of regulatory submissions. The candidate will be the leading authority within the company to implement new guidance’s and technologies, provide regulatory requirements for submission of documents to regulatory authorities (complexity of job, time required, etc.) This person must be highly organized, skilled in effective communication and negotiation, able to manage a growing group, able to multitask, work well within the team setting, and prioritize work to meet critical timelines.
Essential Skills:
-Manage a team of regulatory documentation professionals
-Keep current on new guidance’s relating to regulatory submission format and publishing -requirements.
