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Senior Vice President, Global Regulatory Affairs & R&D Quality
A career with EMD Serono is an ongoing journey of discovery: our 56,000 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.
Based in Darmstadt, Germany or in Billerica MA, USA, the SVP and Global Head of Regulatory Affairs and R&D Quality will be responsible for the regulatory strategy and implementation as well as the relationships with the relevant authorities in the regions of the world.
- Create the vision and design the long-term Global Regulatory Affairs (GRA) & R&D Quality (RDQ) strategy and operating model for the company
- Successfully balance two primary objectives, driving both the innovation project pipeline and marketed product portfolio
- Successfully motivate and engage a diverse global team of experts and professionals in all areas of the business
- Continue the evolution of GRA & RDQ with the implementation of new Operating Models and key transformative initiatives
- Ultimate decision-maker for GRA on all critical submissions to all regulatory agencies
- Alignment of the regulatory business model with the Global R&D strategy and governance
- Create business value through regulatory action and strategy
- Influence the external regulatory competitive environment
Scope of People Responsibility:
- Head the GRA & RDQ leadership team to ensure delivery
- On project and portfolio commitments
- Transformative functional initiatives
- People and resources
- Budget Adherence
- Lead by example, consistently demonstrating behaviors which are aligned with company values & capabilities
- Ensure technical competence & transparency in interactions with regulatory agencies worldwide
- Maintain Compliance standards
- Strategic Impact Develop and lead the implementation of the global regulatory & R&D quality strategies and vision for the company. Oversight includes all aspects of regulatory affairs (i.e. strategy for product development and life-cycle management, scientific and regulatory policy, operational excellence with submission & information management, regional and country oversight). Product categories include small molecules, biologics, biomarkers and diagnostics
- Design and drive the functional vision, adapting to an evolving external market, capricious global conditions and rapid advances in technology.
- Will be a member of the company’s R&D Executive Leadership Team
- Coordinate and collaborate with internal stakeholders for business decisions impacting GRA & RDQ as well as the broader Healthcare organization
- Represent GRA & RDQ externally, including interactions with key opinion leaders
Who You Are:
- Doctorate in Pharmacy, Medicine or Life Science or related discipline
- Excellent spoken and written English
- Minimum of 15 years of industry experience, with positive track record in global regulatory submissions, life-cycle management, with experience in regulatory risk & crisis management.
- Experience leading small and large teams of professionals
- Demonstrated expertise in Regulatory Affairs & Quality globally, influencing the global regulatory and business environment, representing industry on committees in interactions with regulatory authorities and experts to agencies.
- Clear proficiency in leading initiatives which impact regulatory decision-making
- Ability to travel internationally and domestically as needed
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.