Senior Director, Head of US Global Regulatory and Scienti

EMD Serono Research & Development Institute•Washington, DC

About The Position

We’re seeking an executive to drive the global strategic development and execution of EMD Serono’s R&D policy agenda, delivering critical regional input to shape portfolio strategy and maximize lifecycle management. The role identifies US scientific and regulatory policy trends that could impact development programs, ensuring insights are leveraged with stakeholders to standardize a global approach and boost asset success. You’ll provide focused regulatory intelligence to regional affairs and product development, and actively engage externally to shape the US policy environment, partnering with cross-functional experts and leading regulatory advocacy through trade associations and guidance consultations.

Requirements

10+ years in drug development/regulatory in biotech/pharma, with at least 2 years in supervisory/management roles
Externally recognized regional regulatory policy thought leader; leads coalitions and advocacy with key stakeholders; heads trade association policy initiatives
Deep knowledge of the drug development process and FDA/ICH regulations; proven in shaping policy agendas and advocacy strategies
Extensive experience advising senior leadership; strong oral and written communication skills
In-depth experience with Trade Associations and related regulatory ecosystems
Demonstrated ability to influence and align senior stakeholders across functions
Proven ability to work effectively in a fast-paced, matrixed, multinational environment
Comfortable collaborating with global executives, government officials, and association leaders
Strong cross-functional leadership and ability to drive a common strategic agenda
High adaptability, initiative, and interpersonal acuity with a teamwork orientation

Responsibilities

Drive the global strategic development and execution of EMD Serono’s R&D policy agenda
Deliver critical regional input to shape portfolio strategy and maximize lifecycle management
Identify US scientific and regulatory policy trends that could impact development programs
Ensure insights are leveraged with stakeholders to standardize a global approach and boost asset success
Provide focused regulatory intelligence to regional affairs and product development
Actively engage externally to shape the US policy environment
Partner with cross-functional experts
Lead regulatory advocacy through trade associations and guidance consultations

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