Associate Director, Regulatory Affairs

Associate Director, Regulatory AffairsRegulatory AffairsJersey City, NJSummaryThe position of Associate Director shall serve as the primary point of knowledge and contact for his/her assigned therapeutic area. Reporting to the Director, this position provides interface with internal and business partner divisions to manage regulatory matters across the lifecycle of assigned products. As the primary point of contact with global regulatory agencies, this position serves as an ambassador for his/her assigned therapeutic area. Successful candidates will effectively manage his/her active product pipeline while monitoring and providing input to strategic matters impacting his/her therapeutic area. Duties and ResponsibilitiesWithin therapeutic area(s) of responsibility: -Serve as a focal point with global regulatory organizations. Develop excellent working relationships with all regulatory agencies resulting in rapid, worldwide approvals for internal and external (client) projects. Build a strong foundation for corporate credibility -Maintain a vigilance of proposed changes and new regulatory legislation. Actively communicate these matters to the appropriate internal parties. Suggest and collaborate on strategies for managing the change. Suggest areas of new opportunity brought about by these changes. -Proactively collaborate with preclinical, clin/pharm, clinical development, commercial (marketing), and manufacturing programs to provide regulatory strategy and direction that will accomplish results for worldwide registrations and regulatory product maintenance activities in a positive manner. -Guide regulatory strategies for worldwide compliance and submissions, from development through marketing, including advertising, promotion, and labeling, in an environment committed to the efficient and aggressive development of new drugs for patients -Help manage and participate in the processes to achieve regulatory agency input into research and development programs. -Communicate with applicable regulatory agencies to ensure efficient drug development and drug approvals. -Actively participate in the development of SOPs and internal standards. -Ensure that all regulatory documents are prepared in accordance with regulatory guidelines and internal standards and SOPs. -Interact with Regulatory Affairs personnel and project team members to define submission logistics and scheduling; coordinate priorities for submissions. -Demonstrate knowledge and competency to serve as the subject matter expert in one or more identified Regulatory affairs core competencies. -Provide direct supervision and career counsel to Regulatory Associate(s). -Provide constructive input and solutions for improving departmental efficiency and effectiveness. Actively work to implement these solutions. -Maintain a high level of expertise through reading and attendance at professional seminars, workshops. -Exercises outstanding judgment in all areas of responsibility. Requirements-Regulatory, Quality & Compliance professional with a minimum of 5 - 7 years of Pharma experience. -Demonstrated knowledge of the following functional areas(within the context of regulatory affairs): Quality Assurance, Labeling Promotion, Drug Safety Licencing, CMC Publishing, Clinical -Proven track record drug (CDER) regulatory affairs, development activities, and clinical activities. -History of successfully interacting with regulatory authorities. -Thorough understanding of submittal of aNDA, IND, NDA, 15 Day Reports, and other regulatory documentation. -Experience with US and International agencies (preferred) -A strong understanding of the interface between clinical development and preclinical research. -Demonstrated leadership and management capabilities Technical Qualifications: -Knowledge of all relevant pharma regulatory procedures and reporting requirements -Experience with document management of INDs, IND Amendments, FDA Briefing Packages, and NDAs. Experience with CTD /e-CTD preparation preferred. -Strong technical background including proficiency in Windows, Microsoft Office, Documentum, and other Forest systems General Qualifications: -Energetic, self-motivated, hands on manager. Efficient multi-tasker who is accustomed to working in deadline-focused, high-pressure entrepreneurial environment. -Ability to manage multiple simultaneous products/projects. -Articulate -- comfortable in both written and verbal communications and presentations -Strategic, analytical thinker with strong business acumen -Proactive, disciplined, organized, and detail-oriented. -Demonstrates consistent logic, rationality, and objectivity when identifying significant problems and opportunities. -Creative problem solver with the ability to establish systems and define standard practices. -Displays high level of integrity by remaining consistent in terms of what he/she says and does in terms of behavior toward others. -Leads by example, fostering high level of accountability through fair, hard-hitting goals and performance-measures. -Willing team player capable of working collaboratively with colleagues in their department and in all functions -High degree of competence without arrogance; represents the department, company, and partnerships with professionalism and credibility. Strong predisposition toward customer service. If you are interested in this position, please apply directly at: http://www.frx.com/careers/job_description.aspx?number=92280or review all of our open positions at:  www.frx.com/careers