B

Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Director, Regulatory Strategy Lead Europe

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeNo salary listed

About the Job

Requirements

  • A Ph.D., M.D., PharmD, MSc, or BSc in a relevant discipline.
  • Extensive regulatory affairs experience, with proven success delivering global or EU regulatory strategies.
  • A track record of successful Health Authority negotiations, including with the EMA.
  • Experience leading cross-functional matrix teams in a complex, matrixed environment.
  • Deep understanding of EU regulatory principles and procedures.
  • Ability to integrate scientific, regulatory, and business thinking into practical, executable strategies.
  • Ability to navigate risk and drive resolution under pressure.

Responsibilities

  • Define and drive EU regulatory strategy across development, registration, and lifecycle management.
  • Lead negotiations with the EMA and other relevant Health Authorities, translating company strategy into outcomes.
  • Build integrated submission plans and translate them into operational deliverables for internal teams and external partners.
  • Integrate scientific, medical, legal, and business perspectives to achieve regulatory outcomes.
  • Provide regulatory guidance to Development Team Leaders and cross-functional stakeholders, proactively resolving complex issues.
  • Monitor and anticipate evolving European and international regulatory trends.
  • Build and nurture relationships with Health Authorities, alliance partners, and EU country colleagues.
  • Travel as appropriate.

Desired Qualifications

  • Prior experience in immunology and/or cardiovascular therapeutic areas in industry, a health authority, or drug development.

About the Company

Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Bristol Myers Squibb discovers, develops and sells prescription medicines for serious illnesses, including cancer, blood disorders, immune diseases and heart disease, for patients treated by doctors and hospitals around the world. Its best-known drug is Opdivo, an immunotherapy that helps the body's own immune system find and attack many kinds of cancer. Researchers develop drug candidates in its labs or bring them in through acquisitions and partnerships, then test them in clinical trials to win regulatory approval. The company makes and markets the approved medicines and earns its revenue from sales of patent-protected drugs. Its roots go back to a business founded in 1887, and it is based in Lawrence Township, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Lawrence Township, NJ
Founded
1887

Recently Posted Jobs

Explore more opportunities at Bristol Myers Squibb

See more jobs