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Director / Associate Director, Regulatory Strategy - Oncology, Global Regulatory Affairs

Company: Takeda
Location: Somerville
Posted on: January 12, 2021

Job Description:

By clicking the ---Apply--- button, I understand that my employment application process with Takeda will commence and that I agree with Takeda---s Privacy Notice, Privacy Policy and Terms of Use.Job DescriptionAre you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Director or an Associate Director, Regulatory Strategy in our Cambridge, Massachusetts office.Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director, Regulatory Strategist working on the Global Regulatory Affairs Oncology team, you will be defining, developing, and leading global strategies to maximize global regulatory success towards achievement of program objectives: OBJECTIVE: Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable.ACCOUNTABILITIES: Leads or supports highly complex or multiple projects within the oncology group. For assigned projects, leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group and Submission Working Group, and represents GRTs at project team meetings.Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.Responsible for ensuring complete submission of INDs, CTAs, briefing packages, responses, and other submissions. Major submissions (NDA/BLA/MAA). Manages the preparation of responses to regulatory agency queries / oversees completion of activity by others.Apply knowledge of global regulatory requirements, in collaboration with regional regulatory leads, to ensure that global consideration is given in development planning.Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Seek and apply innovative regulatory approaches to accelerate development and approvals.Participates with influence in or leads departmental and cross-functional task-forces and initiatives.Responsible for demonstrating Takeda leadership behaviorsEDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:Bachelor's Degree is Required. Bachelor of Science is preferred. Bachelor of Arts will be accepted8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5 years regulatory and/or related experience. Oncology experience strongly preferred. Experience in early stage oncology development and/or immuno-oncology is a plus.Experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in establishing and building appropriate regulatory strategy.Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.Must work well with others and within global teams. Able to bring working teams together for common objectives.TRAVEL REQUIREMENTS:Willingness to travel to various meetings, including overnight trips.Requires approximately up to 10-30% travel.WHAT TAKEDA CAN OFFER YOU:401(k) with company match and Annual Retirement Contribution PlanTuition reimbursementCompany match of charitable contributionsHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach ProgramsEmpowering Our People to ShineLearn more at takedajobs.comLI-JV1LocationsCambridge, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeFull time

Keywords: Takeda, Somerville , Director / Associate Director, Regulatory Strategy - Oncology, Global Regulatory Affairs, Executive , Somerville, Massachusetts

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