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Global Regulatory Portfolio Lead & US Head Oncology

 

A career with EMD Serono is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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.

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

 

Your Role: The Global Regulatory Affairs Research and Development department (GRA R&D) drives the regulatory strategy and Health Authority liaison activities for Health Care products. This position reports to the Head of Global Regulatory Affairs – Oncology and Companion Diagnostics and is responsible for leading the US GRA team and ensuring optimal regulatory strategies are developed and executed for projects in the oncology and immuno-oncology portfolio, understanding the competitive environment and global regulatory landscape.

Specifically:

  • Global Portfolio Leader for selected development projects (early and/ or late stage) in the oncology portfolio
  • Direct leadership of US GRA Oncology team. Manage direct reports responsible for regulatory strategy, submissions, and health authority liaison activities for the Company’s oncology portfolio from the initiation of development through to commercialization. 
  • 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 direct reports
  • Provide leadership to ensure sound regulatory strategies are in place to support development programs and 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 expedite review and approval of submissions
  • Drive 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 partnerships and optimize effective working relationships.

 

Who you are:  

Minimum qualifications:

  • A strong leader and experienced manager of staff and regulatory teams with recent experience in oncology development
  • Experienced strategist with a record of successful FDA interactions supporting significant oncology submissions, including original NDAs/BLAs, efficacy supplements.
  • Advanced degree and minimally 10 years of relevant regulatory experience

 Preferred qualifications:

  • Skilled at attracting, developing, and maintaining talent
  • Willingness to travel both domestically and internationally

 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

 

If you are a resident of NYC or Connecticut, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

 

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.

 

As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.

Job Requisition ID:  243309
Location:  Billerica
Career Level:  E - Professional (10+ years)
Working time model:  full-time

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request.  You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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Nearest Major Market: Boston

Job Segment: Oncology, Neurology, Developer, R&D, Healthcare, Technology, Research

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