Executive Job Description | NJ Biotech Company: Vice President, Global Regulatory Affairs & QA
Location: Central NJ
Reports To: Chief Medical Officer
Compensation: $250k+ base, bonus and more
Our client is a global biopharmaceutical company in Central New Jersey. We are seeking high energy individuals who are ready for this exciting opportunity and the chance to further establish your career. If you have an advanced degree, with several years leading a regulatory affairs team, this may be the next best step for you! We are looking for dynamic leaders who want to work in a cutting edge environment and want to create impact in a company working to make a difference. For immediate and confidential consideration, please send a Word version of your resume and note the site you saw the posting.
Summary
As the most senior executive responsible for the global regulatory, quality, and compliance functions, the Vice President, Regulatory Affairs & QA is responsible for the development, implementation, and direction of effective regulatory and quality strategies. The position oversees the implementation of strategies for earliest possible approvals of Phase I through Phase IV applications. The position has responsibility for tracking and evaluation of governmental and international regulations and their impact relative to drug regulation. The incumbent must build and maintain excellent relationships with the FDA, other health authorities, and corporate partners while advocating the company’s position.
Duties and Responsibilities
• Responsible for overseeing the company’s global regulatory and quality strategies and policy development, and directing the functional resources related to those areas.
• Represent company with domestic and international (EMEA / EU and ROW) health authorities.
• Ensure compliance with regulatory requirements for submissions; plans and oversees INDs, IMPDs, CTXs, NDAs, CTDs, BLAs, MAAs, Annual Reports, and other regulatory submissions.
• Review of proposed changes to regulated processes and / or products to identify regulatory implications.
• Review of Final Study Reports, Manufacturing Process Documentation, Investigator Brochures, Clinical Study Protocols, and clinical trial documentation for compliance with cGCPs, cGMPs, cGLPs and other appropriate regulations and guidelines.
• Develop and implement comprehensive regulatory strategies for the company’s drug and biological products.
• Act as primary liaison and coordinate meetings with FDA, EMEA, and other regulatory agencies as needed.
• Manage and provide internal training for FDA, EMEA, ICH guidelines and regulations.
• Interact with key scientific, clinical research, marketing and commercial personnel within and outside Company to ensure timely and accurate regulatory compliance.
• Direct the review and provide regulatory guidance on labeling, promotion, and advertising as appropriate.
• Communicate the company’s position on Quality to internal stakeholders and external partners.
• Provide operational back-up for the Head of Quality.
• Evaluate drug licensing candidates regarding potential for regulatory success and timeline for approval.
• Provide organizational leadership for worldwide regulatory and quality professionals.
Requirements
• Advanced degree in scientific discipline, (Ph.D., M.D. or PharmD) required.
• 10+ years experience in the pharmaceutical / biotech industry as regulatory professional with several successful NDA / BLA submissions.
• Experience in all phases of regulatory submissions and interactions, ideally including post-approval experience; international experience also required; direct contact and negotiation experience with the FDA.
• Experience in leading the Quality function for a biopharmaceutical company and familiarity with GxPs.
• Excellent communication skills; team member that can work collaboratively with colleagues across all functions.
• Excellent analytical, presentation, and writing skills are required.
• Senior managerial experience in a small company environment is desirable.
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