A career with EMD Serono is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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.
As part of the Global Regulatory Affairs Research and Development department (GRA R&D) you will be responsible for regulatory strategy and Health Authority liaison activities for development products. In this role you will be 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 GRA staff, resources, and initiatives.
- Function as the Global Regulatory Lead and US/EU 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.
Who you are:
- Advanced degree and minimally 10 years of relevant regulatory experience
- At least 5 years of recent oncology experience leading and managing teams
- Experienced strategist with a record of successful FDA interactions supporting significant submissions, including original NDAs/BLAs, efficacy supplements
- Demonstrated Leadership capabilities
- Skilled at attracting, developing, and maintaining talent
- Willingness to travel both domestically and internationally
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.