Senior Director, Global Regulatory Affairs, Oncology

Posted 15 Aug 2018

Billerica, Massachusetts - United States

Req Id 179915

Details

A career with EMD Serono is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 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.


Your Role:

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 assets in the oncology and immune-oncology franchise, ensuring ‘One Voice’ for GRA and global alignment for all development projects, managing GRA staff and resources.

 

Specifically:

  • Responsible for regulatory strategy, submissions, and health authority liaison activities for the Company’s oncology and immune-oncology portfolio from the initiation of development through to commercialization. 
  • Manage GRA Development resources for the therapeutic area, ensuring project coverage and resource allocation
  • Generate hiring plans to support the 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
  • Ensure adequate training and mentoring of employees
  • 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 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 leadership/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 at least 12 years of relevant regulatory experience
  • Regulatory professional with at least 5 years of recent oncology or immune-oncology experience leading and managing global teams
  • Experienced strategist with 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
  • 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 come2emd.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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

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