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 Head of Regulatory Affairs, U.S. is accountable for the U.S. regulatory strategy and operational execution for approval and life cycle management of all products to be marketed in the U.S.. This includes but is not limited to initial and ongoing label optimization, FDA interactions including negotiations, U.S. regulatory submissions, Advertising and Promotional activities, and also a critical role on the Safety Review Committee. In this role this individual must work highly collaboratively in a matrix structure with key members of the Global Regulatory organization as well as with U.S. leadership. This position reports directly to the Head of Global Regulatory Affairs & RDQ.
- Provide overarching U.S. regulatory strategy (both launch and LCM) for all programs taking into account business objectives and the local regulatory environment
- Partner effectively with Global Regulatory functions (e.g., Global Labeling, Global A&P, Global regulatory development leads, etc.) to ensure appropriate U.S. input at early stages of critical decisions and to ensure adherence and pull through of Global processes and guidances
- Participate in (and lead as appropriate) all interactions with the FDA, including leading label negotiations
- Identify and execute on opportunities to build a relationship of trust, scientific credibility, and partnership with relevant stakeholders within the FDA, leading to early engagement with the FDA to accelerate development
- Attend all FDA open, public meetings relevant to the business (i.e., patient engagement, advisory committee, input on guidances, etc.)
- Develop a highly skilled team that partners effectively in the broader matrixed organization to deliver an aligned and successful regulatory strategy
- Ensure compliant and timely operational execution of all required regulatory updates, submissions, and reporting responsibilities
- Be the face of EMD Serono at key regulatory industry meetings (i.e., FDA/CMS Summit, FDLI, DIA, etc.)
- Serve on the Safety Review Committee to represent the U.S.
- Serve as a key member of the North American Leadership Team, serving as the primary link between the U.S. and the Global Regulatory Affairs organizations
Who You Are:
- Bachelor’s Degree in scientific or life sciences discipline or related required, Advanced degree in scientific or life sciences discipline or related (PharmD, PhD, MD) strongly preferred.
- 20+ years’ experience in the biopharma industry, with at least 10+ years in a lead role within U.S. regulatory affairs
- Demonstrated experience and excellence in Promotional and Advertising review for both LCM and launch with specialty products
- Proven track record of effective collaboration with the FDA, demonstrated ability to act as a credible, influential, respected spokesperson during interactions with the agency
- Gravitas to negotiate within a highly matrixed environment to deliver complex messages and facilitate appropriate team decisions, insightful and forward thinking, ability to recognize, anticipate and proactively manage upcoming U.S. regulatory needs
- Actively engages colleagues, interacting broadly with other members of GRA, the North American Commercial Team, and other global functions (i.e., US Legal, US Compliance, US Medical Affairs, etc.)
- Demonstrated leadership experience
- Demonstrated track record of success contributing in a globally oriented environment
- Understand small molecules, biologics processes, devices, diagnostics and manufacturing aspects of product development for both oral and infusion specialty products
- Skilled in presenting management with recommendations that reflect full consideration of available options and a strong business judgement on balance of risk
- Communicate with clarity, impact, and passion tailored to the audience
- Ability to travel up 20% of the time
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.