A career with EMD Serono is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
The Global Regulatory Affairs Research and Development department (GRA R&D) is responsible for regulatory strategy and Health Authority liaison activities for Health Care products. This position reports to the regulatory Therapeutic Area Head and is responsible for setting the GRA strategy for projects in the oncology and immuno-oncology portfolio, understanding the competitive environment and global regulatory landscape, ensuring alignment and 'One Voice' for GRA , and managing GRAstaff, resources, and initiatives.
Function as the Global Regulatory Lead for 1 or more development projects in the oncology portfolio
Create an environment that attracts, develops, and maintains high quality employees
Ensure consistent roles, responsibilities, and clear accountability for oncology staff aligned with the GRA operating model
Manage direct reports (as assigned) responsible for regulatory strategy, submissions, and health authority liaison activities for the Company's oncology portfolio from the initiation of development through to commercialization.
Ensure adequate training and mentoring of direct reports
Provide leadership to ensure sound regulatory strategies are in place to support development programs and to ensure functional alignment within the regulatory organization
Lead, influence, and defend regulatory position with health authorities (HAs) and EMD Serono governance committees; act as a credible, influential, respected spokesperson during interactions with HAs and ensure proactive communication with agencies to expedient review and approval of submissions
Ensure successful registration of development assets, exert influence through interactions with Health Authorities and contribute to shaping the regulatory environment for the portfolio
Participate in governance committees, cross-functional and GRA initiatives; build partnership and optimize effective working relationships, shape or drive regulatory contribution and influence
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