Associate Director, Global Regulatory Affairs, Precision Medicine & Digital Health

Takeda•USA - MA - Virtual, MA

16h•$154,400 - $242,550•Remote

About The Position

Provides strategic and tactical guidance to teams for the delivery of global regulatory strategies to support development and commercialization of biomarkers, diagnostic tests, devices and digital health tools to enhance the value of our products across therapeutic areas and to ensure goals/objectives are met.

Requirements

Bachelor’s Degree, scientific discipline strongly preferred
A minimum of 5 years of experience in regulatory affairs.
Experience working with medical devices and/or diagnostics within the pharmaceutical industry strongly preferred.
Proven track record in developing and managing regulatory strategies for digital health products, and/or diagnostics, and precision medicine.
Expert knowledge of device development, registration and maintenance requirements with experience in championing innovation in technical areas.
Comprehensive understanding of biomarker strategies and implications for drug development.
Demonstrated track record of successful interactions with FDA, EMA, Notified Bodies, and other global health authorities specifically related to Device submissions (i.e., IND, SRDs, IDEs, CTA, IMPD, BLA, MAA, NDA, 510K, CE Mark submissions and their amendments/supplements).
Understanding of scientific principles and device regulatory requirements relevant to global drug development and post-market support, including EU MDR and IVDR.
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 established and building appropriate global regulatory strategy.
Demonstrates strong verbal and written communication skills, with the ability to translate complex regulatory concepts into clear, stakeholder-tailored communication

Nice To Haves

Advanced degree in a scientific discipline (PhD., M.D., PharmD, MS) strongly preferred

Responsibilities

Responsible for developing and leading the global regulatory strategies for precision medicine and digital health efforts for assigned programs.
Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.
Partner with local/regional regulatory representatives to lead and support lifecycle management regulatory activities for the digital health and precision medicine portfolio, including change impact assessments, regulatory strategy alignment, and execution of required maintenance submissions/notifications to ensure ongoing compliance across markets.
Ensures therapeutic asset’s global regulatory plans effectively accommodate appropriate precision medicine approaches by effectively integrating drug and diagnostic regulatory and submission plans including HA engagement plans and mitigation strategies
Ensures 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.
Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with management; understands probabilities of technical success for the solutions.
Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internal governance technical review committees, key global health authority meetings and with external partners.
Participates with influence in or leads departmental and cross-functional task-forces and initiatives.
Influence cross-functional colleagues within the therapeutic area, across GRA and across the enterprise.
Provide training to cross-functional teams to enhance their understanding of regulatory requirements and processes.
Helps implement a culture of continuous improvement to improve regulatory processes, and drive the adoption of innovation and best practices within the regulatory function.
Provide regulatory strategy support to diligence for licensing opportunities as appropriate, including regulatory input on the selection, governance, and ongoing management of device/diagnostic partners.
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.
Support external influencing activities by coordinating and contributing to regulatory/policy engagement efforts, including drafting and reviewing guidance comments and supporting trade association working groups.