Senior Director, Global Regulatory Affairs Oncology
EMD Serono

Billerica, Massachusetts

Posted in Science and Research


This job has expired.

Job Info


A career with EMD Serono is an ongoing journey of discovery: our 58,000 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.

Your Role:

The Global Regulatory Affairs Research and Development department (GRA R&D) is responsible for regulatory strategy and Health Authority liaison activities for Health Care products. This position reports to the regulatory Therapeutic Area Head and 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 GRAstaff, resources, and initiatives.

Specifically:

Function as the Global Regulatory Lead for 1 or more development projects in the oncology 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

Manage direct reports (as assigned) responsible for regulatory strategy, submissions, and health authority liaison activities for the Company's oncology portfolio from the initiation of development through to commercialization.

Ensure adequate training and mentoring of direct reports

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 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 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 governance committees, cross-functional and GRA initiatives; build partnership and optimize effective working relationships, shape or drive regulatory contribution and influence

Who you are:

Minimum qualifications:

  • Advanced degree and minimally 10 years of relevant regulatory experience
  • At least 5 years of recent oncology experience leading and managing teams
  • Experienced strategist with a record of successful FDA interactions supporting significant submissions, including original NDAs/BLAs, efficacy supplements

Preferred qualifications:
  • 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 athttps://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.

Job Requisition ID: 220923

Location: Billerica

Career Level: E - Professional (10+ years)

Working time model: full-time


This job has expired.

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