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Global Regulatory Portfolio Leader ( GRPL )

The purpose of this role is to: Be the principle regulatory representative for the designated Portfolio/ Disease Areas within the RU Pipeline and Product Development Oversee the designated Portfolio at the governance, strategic and technical level. Be accountable for the Regulatory Strategies and effective Global Regulatory Sub Teams (GRST) working within the assigned portfolio, ensuring aligned regulatory positions in place and agreed that take into account regional needs early in development Provide strategic guidance to projects and products through regulatory strategists reporting to him/her. Model strong leadership and project management techniques to provide leadership to the GRA teams, committees or work units to develop objectives, strategy, and tactical plans for the portfolio, assuring a global focus of goals, strategies and plans. Responsible for developing collaborative working relationships with the regulatory authorities and influencing emerging regulatory/policies in general and particularly in the associated portfolio/disease areas. Supervise US/EU/EM regional regulatory strategist leads and/or Global Regulatory Leads (GRLs), and responsible for staff and talent development, career development and planning and performance management. Ensure regulatory deliverables in place and delivered to time, cost and quality for all projects in the portfolio (line plan/LAD/PRS/regulatory risks). Contribute to the GRA Leadership Team and drive the required culture and behaviors though the organization. Champion flexible approaches to ensure efficient and effective resource utilization. Ensure learning embedded in the organization. ROLE RESPONSIBILITIES Senior global regulatory representative within the specified portfolio/disease areas, at the governance, strategic, technical, and portfolio level responsible for regulatory decisions Provides regulatory expertise and leadership within the assigned portfolio Responsible for developing and maintaining an in-depth regulatory knowledge of the portfolio including current and emerging global guidelines and regulators, relevant regulatory approaches and actions; and status of competitor products Responsible for ensuring global regulatory strategies for all projects and products within the assigned portfolio are developed and implemented Partners with leaders in Category RU and Global Product Development to develop strong regulatory strategies for projects and products. Develops strong and positive working relationships with regulators, professional bodies, external experts and opinion leaders. Develops novel  concepts and approaches to advance and/or challenge existing regulatory paradigms in support of pipeline products Works closely with regulatory colleagues across sites, countries and Categories to ensure consistent approaches to Health Authorities.  Engages in appropriate activities to influence the regulatory environment. Responsible for aggregate resource forecasting for the projects/products within assigned portfolio. Mentors, develops and coaches Regulatory Strategists/GRLs for projects within the relevant portfolio including all aspects of the performance management process as appropriate. Provides guidance to all regulatory professionals within the area of responsibility to prepare for health authority interactions and external and internal project/product presentations Works with other regulatory staff to ensure application of consistent processes and policies across GRA. Directly responsible for assuring implementation of these processes and policies. Supports the GRA leadership team and drives the required culture and behaviors through the organization QUALIFICATIONS Advanced Scientific Degree (MD, PhD, PharmD, M.Sc.) Demonstrable experience in drug development or relevant experience in the Pharmaceutical industry, preferably in Drug Development or Clinical Research, ideally within Regulatory Affairs / Health Authority and/or a proven track record of success in negotiating with Health Authorities and in representing interests to internal and external stakeholders Knowledge of assigned therapeutic areas / disease areas; experience in early and full development of novel therapeutics In depth and relevant Global regulatory experience (more than one region) Demonstrated strategic thinking and ability to integrate strategies into actionable plans; exhibits innovative thinking Proven ability to function autonomously at a senior level in a highly matrixed organization; exhibits business acumen. Demonstrable experience of managing others and leadership. 4725340
Salary Range: NA
Minimum Qualification
Not Specified years

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