Global Regulatory Lead, Oncology & Submissions

Merck; Boston (MA); Hybrid; USD 129,000 - 203,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

401(k) and comprehensive benefits

Hybrid work arrangement

Job summary

Merck’s Regulatory Affairs team in Boston seeks an Associate Director to help shape global regulatory strategy for oncology products. You will work with global leads to support registrations and lifecycle management, coordinating across clinical, CMC, and regulatory operations to drive submissions and Agency interactions.

The role emphasizes strong communication, regulatory science, and project leadership with a focus on oncology programs and continuous process improvements.

Qualifications

• Experience in drug development and regulatory approvals.
• Excellent communication and collaboration with global teams.
• Strong analytical and regulatory writing skills.

Responsibilities

• Assist regulatory agency communications and submissions, including INDs and marketing applications.
• Develop and implement global regulatory strategy for registrations and maintenance.
• Collaborate with cross-functional teams across Clinical, CMC, and Regulatory Operations.

Skills

Regulatory strategy

Global regulatory

Regulatory submissions

Stakeholder engagement

Education

Bachelor's degree

Master's degree

Doctoral degree (MD/PhD)

Job description

Merck’s Regulatory Affairs team in Boston seeks an Associate Director to help shape global regulatory strategy for oncology products. You will work with global leads to support registrations and lifecycle management, coordinating across clinical, CMC, and regulatory operations to drive submissions and Agency interactions.

The role emphasizes strong communication, regulatory science, and project leadership with a focus on oncology programs and continuous process improvements.