Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.  Job #02867 About our client Our client is a well established biologics (allergy extract) located in beautiful Western North Carolina. The company, founded in 1904, is a leader in developing and providing allergy immunotherapy products/services for treatment of human beings and animals. In addition to their current product line, they have clinical trials also in process. Position Location Senior Manager, Regulatory Affairs  North Carolina Salary Highly competitive package, commensurate with experience Responsibilities 1) Ensure company’s compliance with applicable regulations including 21 CFR Parts 210, 211, 601 and 820 2) Make regulatory submissions such as clinical INDs and supplements to existing BLA licenses 3) Ensure proper communication and corporate compliance with changes in FDA and other regulatory agency changes 4) Develop (proactively) a positive relationship and negotiate directly with regulatory authorities regarding the company’s submittals and filings 5) Supervise the Regulatory Manager directly 6) Improve the content of submittals (continuously) Requirements 1) BS (Master’s degree preferred) 2) 10 years of regulatory affairs experience in a pharmaceutical/medical device company 3) 3 years of experience in upper management of a small pharmaceutical or biotech company 4) Experience in submittals and IND negotiations 5) Expertise in preparing the company for inspections by FDA and customers 6) Experience in FDA inspections and writing FDA reports (annual budgets) 7) Experience in 483 responses and preventing their occurrence 8) Ability to manage, prioritize as well as to divide tasks to ensure that all submittals are on time 9) Excellent communication and organizational skills 10) Ability to continuously improve GMP compliance 11) Ability to write or contribute to annual reports, product reviews and supplements 12) Good computer skills and basic knowledge of common PC spreadsheet and word-processing software 13) Detail- and goal-oriented as well as ability to take on new and exciting projects
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