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Job #03462

About our client Our client is a publicly traded pharmaceutical company located in southern California that specializes in development and commercialization of Pulmonology and Hepatology therapeutics. The organization has an experienced management team, a world-class corporate culture and an established reputation for being a leading innovator in the field. Position Location Sr. Director/VP of Regulatory Affairs California Salary Highly competitive package, commensurate with experience Responsibilities 1) The specific title and breadth of responsibilities for this position will be contingent on the experience level presented by candidates 2) This is a senior level position in the Department of Regulatory Affairs responsible for successful global regulatory support of biological and drug products for the company’s drugs in development, as well as one marketed product 3) The immediate focus for the person who assumes this role will be to lead the regulatory MAA activities and assist with the NDA activities, the 120-day Safety Update, the Advisory Preparation activities and the Labeling negotiation process 4) Other duties will include regulatory representation and leadership to cross-functional product development teams, development of regulatory strategies, and, submission support for the company’s early and late stage clinical development programs, non-clinical development programs, license support and post-marketing activities 5) This position is also responsible for internal and regulatory agency interactions involving the review and development of the company’s labeling and promotional materials 6) Reporting to the Chief of Medical Affairs and Regulatory, this position will oversee the Regulatory Department and the MAA activities and assist with the NDA activities 7) The incumbent will be responsible for leading his/her team, developing their regulatory expertise, and, will act as role model and mentor to the department 8) The position will hold primary accountability for the success of interactions and negotiations with domestic and foreign regulatory agencies on assigned projects and will manage regulatory activities according to corporate goals and timelines 9) Additionally, this individual will actively participate in various administrative activities to maintain the company’s Regulatory Affairs department as a compliant and highly effective organization 10) Provide primary regulatory leadership for MAA submission activities and responses to the EMEA 11) Assist with NDA submission activities, 120-day Safety Update, Advisory Committee Preparation, and Label negotiations 12) Proactively provides strategic regulatory guidance and direction to the organization. Clearly delineates the recommended “path to approval” for Product Development Teams and actively manages according to development timelines and defined strategies. Provides strong regulatory leadership and representation / leadership to Product Development Teams 13) Has primary regulatory accountability for all products in development and one marketed product. This includes the non-clinical, clinical, license and post-marketing activities 14) Accountable for successful negotiations and interactions with domestic and foreign regulatory agencies on assigned projects 15) Liaises with the company’s Marketing, Clinical, Medical Affairs, Technical Operations, and Legal functions in the proactive review and development of all promotional and medical educational materials 16) Proactively assesses the state of compliance of labeling and promotional materials with relevant regulations and provides specific detailed actions to correct deficiencies 17) Proactively participates in and provides regulatory leadership to the multi-disciplinary Promotional Review Committee in evaluation of marketing and sales materials 18) Proactively participates in and provides regulatory leadership to the multi-disciplinary Medical Review Committee in evaluation of non-promotional medical information / educational materials 19) Manages the negotiation and submission of US promotional materials to CDER’s Division of Drug Marketing, Advertising, and Communication (DDMAC) 20) Assists in the management of all aspects of label development including, but not limited to the creation/maintenance of US package inserts, EU SPCs, leaflets, and, corporate Core Data Sheets 21) Interacts and liaises with corporate partners in order to achieve common goals 22) Actively supports risk assessment, project planning and time-line development activities 23) Leads internal and external activities with his/her team to ensure the prompt provision of high-quality, “reviewer-friendly” information in accordance with regulatory requirements and development strategies. 24) Serves as a mentor to the department and responsible for the administrative management and development of his/her team 25) Applies leadership in establishing operational and quality standards within the department, and takes the necessary steps to ensure training and consistency with department standard operating procedures 26) Advises corporate personnel regarding regulatory strategic recommendations, potential areas of concern and new governmental/regulatory developments 27) Provides assistance as needed to the Chief of Medical Affairs and Regulatory 28) Manages the Regulatory Affairs Department by determining staffing needs, tracking budgets, establishing departmental systems, etc. 29) Report to Chief of Medical Affairs and Regulatory Requirements 1) BS/BA or higher in a scientific discipline 2) A minimum of 12 years US bio-pharmaceutical experience. At least 10 years experience at a senior regulatory affairs level in a company involved in the development, manufacture, testing and distribution of ethical pharmaceuticals, preferably biological products 3) Direct MAA and NDA leadership experience is critical 4) Keen understanding of the global drug development process 5) Proven ability to lead highly-effective cross-functional teams and achieve targeted results 6) Extensive experience in the regulatory review of promotional and labeling materials 7) Strong oral and excellent written communication skills 8) Solid working knowledge of Good Clinical Practices (GCPs), current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLP) 9) Demonstrated successful track record in the preparation/submission/review of INDs, BLAs, NDAs, NDSs, MAAs, Annual Reports, Amendments and Supplements