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Job #03169

About our client Our client is a top 10 pharmaceutical company that has established a reputation as one of the most desirable companies to work for in North America. With operations around the globe and an empowering corporate culture that is focused on the professional development of its employees, this is a strong opportunity for the right candidate. Position Location Assistant Global Regulatory Manager Strategy New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Plan and manage global regulatory drug activities for assigned projects within a specific therapeutic area 2) Achieve submission and approval of new chemical entities 3) Oversee all communications with a specified regional Health Authority (EU agencies including EMEA or FDA) for the assigned products 4) Participate in decision making on all key development questions as a member of the Project Team 5) Participate in all decisions that impact the regulatory dossier and approval processes, i.e. pre-clinical and clinical study and program designs, licensing, etc. 6) Ensure submissions to enable timely start of the clinical trials for the assigned development products 7) Implement the regulatory strategy for assigned projects by designing and assessing regulatory strategy options on a regional and global level 8) Oversee the development of initial target labeling (and competitor labeling) in close cooperation with GRA Global Labeling 9) Oversee all communication with the regional health authority in the assigned region for his/her specific projects 10) Track all communications and requests in appropriate contact reporting databases and ensure appropriate internal and external communication of all regulatory relevant issues 11) Lead a Global Regulatory Team (GRT) and coordinate worldwide regulatory input into the global development plan for assigned projects 12) Ensure that the target labeling and regulatory strategy plans address the needs of the specifically assigned region (Global/US/EU) 13) Act as the primary interface between the company and the local Health Authority (HA) 14) Organize and drive preparations for meetings and teleconferences with HA officials to discuss compliance matters or issues that may arise during the development of a new product 15) Ensure development, completion and submission of any materials to HA for such meetings 16) Interact with functions to provide input for the collection, review and assembling of the scientific and administrative sections of submissions to regulatory agencies for an investigational/licensed product 17) Create and/or manage a strong network for assigned projects with the health authority in the assigned region and other key regulatory influencers and stakeholders 18) Facilitate the incorporation of regulatory intelligence and influence into the regulatory project strategy with the goal to increase overall approval chances Requirements 1) Advanced technical degree (Ph. D., MS, MD, DVM or Pharm. D. in Biomedical Science) or equivalent education with 3+ years of direct experience in biomedical research activities 2) 5+ years of experience in regulatory affairs and working directly with the FDA 3) Willingness to travel internationally (up to 30%)