Global Regulatory Affairs

We help healthcare organizations to be an innovative science-driven company by bringing quality solutions to customers and patients.

Imran Shah SVP, Global Regulatory Affairs & Quality

Our experienced team works collaboratively across the company - through the entire drug development process while also supporting our marketed portfolio – in short, following a product from sunrise to sunset.

Focusing on both global and local regulatory strategy allows us to span multiple functional areas including CMC, operational excellence, global policy, and overall strategy. It is an exciting time in Regulatory Affairs as we work toward accelerated approval pathways, and learn how to incorporate patient perspectives most effectively in all that we do.

Now that you know a little about us, we would love to hear more about you!

Our functional groups consist of:

  • Regulatory Strategy by Therapeutic Area Specialty - (Oncology, Immunology, Neurology, Companion Diagnostics, Fertility, Global Health & Established products)
  • International Regulatory Affairs - (Regional and Country Reg Affairs & the Regulatory Excellence Center)
  • Regulatory Operations -  (Project & Submission Management, Vendor Management, Compliance & Information Management)
  • Regulatory CMC - (Biologics, Chemicals & Devices)
  • Global Labeling & Advertising / Promotion - (Global & US)
  • R&D Quality - (Auditing, Inspection Readiness, System Validation)

Curious about our Pipeline?

We translate science and technology into internal innovation and external collaborations with the goal to have the power to change lives. Now more than ever, we’re keeping digitalization at the forefront of it all.

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Meet Our Global Regulatory Affairs Leadership Team

We are a diverse team, with colleagues located throughout the world, each of whom possess a breadth of expertise from regulatory strategy (both global and local), to CMC, to operational excellence, to global policy.

We are expanding

Our new Billerica Horizon building is designed to empower bold ideas:

  • Bright, open and airy spaces for our R&D teams to come together and envision new possibilities
  • 40,000 square feet of laboratories with cutting-edge technologies designed to support innovative R&D processes
  • Fully adaptable laboratory spaces that can accommodate process changes and growth

We look forward to seeing how the Horizon building shapes the work of our passionate scientists.

Voted Best Place to Work

In an unprecedented year that has greatly impacted the way we work and live, we’re thrilled to be named, alongside our colleagues at MilliporeSigma and EMD Electronics, a Boston Business Journal’s “Top Places to Work”!

Voted Best Benefits

Loving your job is about more than just a paycheck.  In addition to competitive compensation and performance bonuses to recognize and reward outstanding work, we also offer a wide range of benefits to all of our employees.  With convenient locations both North and South of Boston, you will avoid the lengthy commute and delays on public transportation when you join our team! Excited to learn more about how our benefits programs help our employees?  

Benefits Information

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