Global Regulatory Affairs

We help the healthcare organization to be an innovative science-driven company by bringing quality solutions to customers and patients. We shape the global regulatory environment, both internally and externally. 

We are agile drivers of strategy to make well-informed Regulatory decisions.  As One, we foster a culture of accountability, collaboration, quality, and trust.

Our goal is to optimize our existing portfolio and maximize the value in our pipeline. We are a trusted strategic partner that drives technology and operational excellence.

What We Are All About

We are relied on for our regulatory expertise throughout the entire lifecycle from discovery to launch that is expanding our footprint in immunology, neurology, fertility and endocrinology, and oncology. With a leadership team comprised of more than 97 years of combined experience we are progressing through a strong pipeline of more than 20 projects in development, including potential new oncology and immuno-oncology projects.

Our functional groups consist of:

  • Global Research and Development Strategy (Regulatory CMC; Regulatory Oncology & Immuno-Oncology, and Immunology & Neurology)
  • Approvals and Launch Strategy, Life-Cycle Management, & Product Maintenance (Labeling, Ad, and Promo; Launch Management, Market Products)
  • Operations R&D and Marketed Products (Project and Submission Management; Application and Data Management; Outsourcing and Vendor Management; Process and Compliance Training)
  • Devices & Diagnostics Strategy (R&D; Marketed Products)
  • Global Regulatory & Scientific Policy (Policy and Intelligence; External and Scientific Policy)
  • Biosimilars Strategy

Why Work for Us?

Your input will be highly regarded within a globally diverse team culture and you will have the opportunity to make an impact every day. You and your team will be results driven, focused on collaboration, and will be encouraged to make effective and efficient decisions while constantly sharpening best practices on regulatory strategies and launch preparedness. You will also be encouraged to share and develop new strategic approaches and process innovation across all Regulatory Affairs and development.

  • With convenient locations on both the North and South Shore in the Boston area, you can avoid lengthy commutes and reliance on public transportation
  • A patient centric mission, the ability to work on the most impactful therapies and make a visible impact everyday 
  • Truly global working environment and access to international career opportunities
  • Dedication to career development planning through on the job training, internal and external education, memberships, and certification programs. Opportunity to take on stretch assignments to gain broader experience
  • Modern work environments with regularly occurring employee events
  • Relocation assistance to Boston area which has a thriving economy, top education and healthcare systems

Be the Worst Enemy…

...of chronic life changing diseases. Find out more about being a part of our Global Regulatory Affairs group and join us on our journey. Go to our job search to see which career opportunities are available.

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What You Will Need to Be Successful

To achieve our mission we would like you to have a background in Biopharma, Pharmaceuticals, Life Sciences, and/or a Regulated Agencies. In addition, you will be someone who possesses the following:

  • The passion and drive to improve people’s lives while growing and developing professionally
  • A results driven mindset and desire to utilize your full potential
  • The ability to continuously seek and implement best practice solutions and new ways of working/technology that will shape the future
  • The desire to experiment and drive change initiatives while being open and encouraging new ideas
  • The ability to drive and influence global initiatives, effective collaboration, and to work together with stakeholders across diverse cultural backgrounds

Our Locations

EMD Serono Research Center

45 Middlesex Turnpike, Billerica, MA 01821

Location

EMD Serono Inc.

1 Technology Pl, Rockland, MA 02370

Location

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