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.
The Global Regulatory Affairs Research and Development department (GRA R&D) is responsible for regulatory strategy and Health Authority liaison activities for development products. This role 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 GRA staff, resources, and initiatives.
- Function as global regulatory leader (GRL) for one or more oncology development programs, and/or US regulatory lead.
- As a key member of Global Project Team(s), influence the development strategy and defend regulatory position with HAs, EMD Serono governance committees
- Lead Regulatory Subteam(s) to ensure development and execution of global regulatory plans and drive development of Global Regulatory Strategy Document
- Responsible for FDA liaison activities and preparation for health authority meetings, globally, ensuring review and approval of regulatory documentation, and ensure successful registration of development asset(s).
- Ensures GAP analysis and risk assessments are performed, define steps for regulatory risk mitigation
- Provide regulatory component of Integrated Development Plans, to achieve the defined Target Product Profile.
- Ensure all regulatory activities are conducted in compliance with relevant laws, regulations and guidelines
- Manage staff (with varying levels of experience), ensuring consistent roles, responsibilities, and clear accountability aligned with the GRA operating model
- Create an environment that attracts, develops, and maintains high quality employees
- Participate in 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 a minimum of 10 years of relevant regulatory experience
- At least 5 years of recent oncology experience is highly desirable
- Experience managing and leading regulatory strategy for therapies for acute, life-threatening disorders, is highly desirable
- A record of successful FDA interactions supporting significant submissions, including original NDAs/BLAs, efficacy supplements
- A strong leader and experienced manager of staff and regulatory teams
- Skilled at attracting, developing, and maintaining talent
- Global experience is desirable
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.