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Job #03265

About our client Our client is a top 10 pharmaceutical company that has established a reputation as one of the most desirable organizations to work for in North America. With a demonstrated commitment to ongoing scientific innovation and an empowering corporate culture that is focused on rewarding top performers, this is a strong opportunity for the right candidate! Position Location Associate Director of Regulatory Affairs New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Act as the Local or Global Regulatory Leader on Global Life Cycle and/or US Product teams for projects of moderate complexity (e.g. Phase 2 programs, post-approval stage, etc.) 2) Provide regulatory leadership to a cross-functional global Life Cycle Team/US Product Team and Regulatory Sub-team 3) Lead the team in developing and delivering a global regulatory strategy for products that balances time, cost, quality and risk 4) Develop global regulatory strategy that meets the needs of patients, prescribers, payers, regulators and the company for an optimal label to commercialize products 5) Ensure global business objectives are understood and taken into account during regulatory strategy development 6) Strategize, plan and execute submissions of varying complexity (global dossiers) to global health authorities 7) Represent the company as lead interface with health authorities (e.g. FDA) 8) Establish effective working relationships with health authorities, direct health authority interactions with teams and with life cycle/regulatory/business teams 9) Ensure cross-functional perspectives/expertise is incorporated into regulatory plans prior to decision-making 10) Manage decision-making and conflict resolution surrounding regulatory issues within the lifecycle/US product teams as well as Regulatory Affairs 11) Ensure appropriate escalation to management when necessary 12) Develop regulatory risk management and contingency plans 13) Communicate plans to the management as appropriate 14) Liaise with planning, finance and functional management to ensure that the Regulatory Team has appropriate budget and resources to meet the set objectives 15) Chair global and/or local regulatory meetings (as appropriate) 16) Motivate and inspire the Regulatory Team to meet objectives 17) Mentor PDR personnel 18) Network and share best practices within function to ensure efficiency and consistency across the teams 19) Analyze the regulatory environment for impact on project/plans and brief Lifecycle/Regulatory Affairs/management (as appropriate) 20) Lead special regulatory projects/global process initiatives (as assigned) 21) Act as a change agent and role model within PDR by modeling best practices 22) Ensure quality and compliance of regulatory activities by adhering to established corporate and functional processes, guidelines and SOPs 23) Serve as a Clinical Team Leader (CTL) on projects whenever required 24) Provide/receive direct and objective performance feedback on/from lifecycle teams, US Product Team and regulatory members Requirements 1) Master’s degree (Ph. D or Pharm. D. preferred) 2) 5+ years of relevant experience as a Senior Regulatory Affairs Manager or Associate Regulatory Affairs Director in the drug industry 3) Demonstrated expertise/knowledge of core processes (discovery, development, manufacturing and marketing) 4) Expertise in leading strategic US regulatory development of products 5) Demonstrated expertise in leading/delivering US and/or global submissions as well as management of filing review process