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Date Last Verified
Years of Experience
ProfileGlobal Regulatory Policy And Intelligence Lead The candidate will develop and help drive strategies and lead processes for global regulatory policy activities. This will include developing internal company positions to support external engagement and proactive regulatory advocacy plans. Also include leveraging intelligence processes and developing value added analysis of external environment trends directly impacting firm's products. This portfolio focused leader will partner closely with project teams and subject matter experts to identify and articulate regulatory policy challenges and develop effective Trade Association and Health Authority advocacy strategies with regional policy leads. Key internal stakeholders include regulatory product teams, R&D project teams, Government Affairs, Value & Access, and Legal. Communicate impact and bring awareness of business-critical global policy issues for informed decision making, and work with regulatory policy leads, subject matter experts within the company to assess impact on firm's products and goals. Maintains expertise of broad regulatory knowledge and policies across product and therapeutic areas as well as general industry trends. Drives engagement to form policy recommendations and advocacy strategies for multinational regulatory and science issues working closely with Regulatory Policy Leads, Regulatory Product Leads, RDPLs and R&D project teams. The focus of these efforts will be on product team and portfolio and decreasing the hurdles to global development of firm's programs. Ability to substitute for Regional Lead's activities as needed. Liaise with regulatory product teams to provide knowledge of emerging regulatory trends to improve the speed and probably of success of firm's regulatory strategies. Participate in R&D/Regulatory processes and initiatives, e.g. GRS pilots and committees, sub teams of Transformation Team, SOP training.
Qualification and Experience
The candidate must have 4+ years of experience working in Regulatory, Regulatory Policy either within a Regulatory Agency and/or in the Biopharmaceutical Industry. Excellent working knowledge of law and regulatory framework and how it applies to Biopharm product development. Must be able to work effectively with a wide range of internal stakeholders to develop, shape, and implement regulatory policies and processes. Must have the ability to lead and influence matrix teams without authority. Demonstrates a strong ability to identify, analyze and solve problems. Able to engage effectively with key stakeholders both internally and externally to successfully influence directions and approaches. Able to facilitate discussions with groups with diverse backgrounds, and help drive decisions on complex issues. Must have excellent written and oral communication skills and an ability to distill complex issues into succinct summaries that clearly convey the specific impact of an issue to the company. Must have degree in law, pharmacy, medicine, or science such as a BS, MS, PhD, PharmD, or MD.
225 Binney Street
Cambridge, MA 02142