Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		Job #07279 About our client Our client is a leading diagnostics company with over 4000 employees worldwide. The company has strong financials, an experienced management team and a robust portfolio of market leading products. This is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Manager of Regulatory Affairs NJ Salary Highly competitive package, commensurate with experience Responsibilities Partial Job Description 1) Assist regulatory management in providing advertising and promotional regulatory review support and serve as local Regulatory Affairs Project Leader for the Latin American project 2) Coordinate, compile and submit filings in support of new indications of currently marketed and potential new products to the FDA and other global regulatory authorities, as requested and maintain the records of those submissions 3) Be responsible for the advertising and promotional sector of US Regulatory Affairs 4) Review draft and final advertising/promotional materials for marketed products and provide input where needed 5) Work closely with Marketing colleagues during the conception/development phase of marketing strategies, promotional pieces, etc. for company products 6) Ensure full compliance of all promotional materials/programs with FDA regulatory requirements 7) Consult/review draft and final initial launch campaigns 8) Ensure full regulatory compliance of all promotional materials with approved labeling 9) Provide training in FDA regulations for advertising and promotion to employees and agents of the company 10) Oversee regulatory content on company web sites for regulatory compliance, including the company website and various product specific websites 11) Review and provide submission letters and FDA forms for responsible submissions going to FDA or other US regulatory agencies 12) Maintain current knowledge and understanding of FDA regulations, guidance and other regulatory standards 13) Provide timely and accurate regulation guidance to key partners/departments to ensure adequate and complete submissions 14) Prepare regulatory forms, review, edit and manage pre-marketing submissions of (including but not limited to) INDs, NDAs, IND Annual and Safety Reports, Clinical protocols, study reports, IBs, progress reports, supplements, amendments, drug shipments, etc. 15) Work directly with key departments to create systems that ensure integrity and quality of submissions in both paper and electronic format (CTD) and assist with the transition of submissions to eCTD format 16) Coordinate and maintain reporting schedules for applications/responses to Health Authorities Requirements Qualifications / Skills Required 1) Bachelor's degree in Life Sciences 2) Minimum of 5 years of broad "hands-on" regulatory-related pharmaceutical experience with an emphasis on post-marketed NDA products 3) Advertising and promotional experience 4) 5 years experience in regulatory affairs 5) Ability to work independently as well as collaboratively 6) Ability to interact with the staff on all levels as well as ability to influence others 7) Ability to demonstrate strong project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral) 8) Ability to organize, prioritize and meet deadlines 9) Ability to work within and maintain an effective team environment 10) Ability to manage multiple regulatory projects and be able to adapt to changing priorities 11) Detail and deadline-oriented individual 12) Excellent planning, organizational and communication skills 13) Strong proofreading skills 14) Self-motivated individual with ability to multi-task with ability to perform duties with minimal supervision 15) Skill in establishing effective working relationships with others 16) Spanish language skills at the business level due for interacting with Latin American customers
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