Global Regulatory Lead – Oncology NDA/BLA Strategy

Meet Life Sciences; Boston (MA); Hybrid; USD 150,000 - 200,000; Full time

Job summary

Meet Life Sciences is seeking a Director / Senior Director, Global Regulatory Lead in Boston, MA to drive regulatory strategy across oncology programs. The ideal candidate will lead NDA submissions and collaborate with various teams, leveraging over 10 years of regulatory affairs experience. The role offers a hybrid work model, requiring 3 days in the office each week, with relocation support provided. A Bachelor’s degree is essential, with a preference for advanced degrees and oncology experience.

Qualifications

• 10+ years of regulatory affairs experience within biotech/pharma.
• Recent, hands-on oncology NDA/BLA submission experience required.
• Proven leadership experience with the ability to influence cross-functional teams.

Responsibilities

• Lead global regulatory strategy for oncology programs from late-stage development through approval.
• Serve as the regulatory lead for NDA/BLA submissions, including planning and execution.
• Act as the primary point of contact with global health authorities.

Skills

Regulatory strategy

NDA/BLA submissions

Leadership

Regulatory requirements knowledge

Cross-functional collaboration

Education

Bachelor’s degree

Advanced degree (PhD, PharmD, MS)

Job description

Meet Life Sciences is seeking a Director / Senior Director, Global Regulatory Lead in Boston, MA to drive regulatory strategy across oncology programs. The ideal candidate will lead NDA submissions and collaborate with various teams, leveraging over 10 years of regulatory affairs experience. The role offers a hybrid work model, requiring 3 days in the office each week, with relocation support provided. A Bachelor’s degree is essential, with a preference for advanced degrees and oncology experience.