Vice President, Cross Pharma Global Regulatory Affairs - ALAMEWA (Asia, Latin America, Middle East, West Africa) - (Job Number: 0802311)

Vice President, Cross Pharma Global Regulatory Affairs - ALAMEWA (Asia, Latin America, Middle East, West Africa) - (Job Number: 0802311) DescriptionThe Cross Pharma Global Regulatory Affairs ALAMEWA department (Asia, Latin America, Middle East/West Asia & Africa) is currently recruiting for a Vice President, Cross Pharma Global Regulatory Affairs - ALAMEWA (Asia, Latin America, MEWA) located in Raritan, or Titusville, NJ. This position is accountable for leading the Cross Pharma Global Regulatory Affairs (CPGRA) ALAMEWA department (Asia, Latin America, Middle East/West Asia & Africa), which provides focused regulatory expertise for the emerging markets for the therapeutic area based business units and associated regulatory affairs departments within the Pharmaceuticals Group. The department is also the functional home for the global regulatory affairs clinical trials group that works with GCO and the R&D companies to ensure successful CTA submissions and on-time clinical trial start-up. The Vice President will drive the strategic direction of the ALAMEWA Regulatory Affairs organization to ensure that it is positioned to effectively anticipate, influence, and respond to changing business and regulatory requirements. Emerging markets are supported through three groups within the CPGRA ALAMEWA department: regional offices (currently 3 ' Asia, located in Singapore; Latin America and MEWA, both located in the US) responsible for the primary interface with the local operating company regulatory affairs staff; regulatory liaisons assigned to R&D companies and global regulatory teams (with direct or matrix reporting into the department), and through a core headquarters team responsible for the development, implementation, monitoring, and ongoing evaluation of standard processes and practices for the regional offices and liaison groups as well as for the management of the GRA clinical trials group. The VP, CPGRA ALAMEWA provides the leadership and management oversight for the department. This position will provide leadership and direct the ALAMEWA Cross Pharma organization, including the Regulatory Affairs Clinical Trials group, to support the goals of the Pharmaceutical group Regulatory Affairs organizations in R&D, Regional, and local operating companies. Provide supervision, mentorship, talent development, standards and training for the department, including direct and matrixed reporting relationships where appropriate, and managing staff at multiple sites and within multiple regions. Influence and lead the organization to identify synergies and efficiency improvements; ensure standardization across regions where appropriate, harmonize ALAMEWA processes across R&D companies, and create consistency in practices and procedures for working with affiliates. For clinical trials, influence and lead the organization to ensure standardization across business units including Medical Affairs as appropriate, and oversee development and deployment of enabling technologies. Set and monitor performance indications for the organization. Develop best practices. As a member of the Cross Pharma senior leadership team, participate in setting strategic and operational direction for the CPGRA organization. Actively participate in other management and leadership forums. A minimum of a Bachelor's Degree is required; advanced degree (MS, PhD) in a scientific or business discipline, or other (MD) highly desirable. Must possess a thorough understanding of drug development and regulatory affairs principles for investigational and marketed drugs, with breadth of global regulatory affairs experience in drug development and commercialization (for example, varied products, multiple therapeutic areas, multiple phases of development) preferred. In-depth experience in global regulatory standards and strategies and knowledge of global Health Authority requirements and expectations, with regulatory experience in at least one major region required. A minimum of 12 years in the pharmaceutical industry expected, with at least 5 years in leadership positions including functional and people management responsibilities. A Minimum of 5 years in Regulatory Affairs with increasing levels of leadership responsibility is required, 8+ years is strongly preferred. Experience in management and supervision in a diverse and global environment required, with experience in managing remote staff preferred. Proven leadership skills in staff development. Track record in cross-discipline and cross-organization collaboration. Ability to thrive in a global, matrixed environment is required. Superior influence and partnering skills expected. Excellent verbal and written communication skills, along with the ability to influence others is a must. Ability to negotiate, influence, and communicate with both internal and external customers is required. This position will require 15% travel both International and Domestic. If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today! Apply Now