Oncology Regulatory Strategy Lead

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

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement benefits

Paid holidays and vacation

Job summary

Merck & Co., Inc. is seeking an Associate Director, Regulatory Affairs to support oncology products within a global regulatory framework.

The role emphasizes collaboration with the global regulatory lead on strategy development, regulatory submissions, and lifecycle management across programs. The candidate will contribute to regulatory science, communicate with agencies, and coordinate with cross-functional teams including Clinical Safety, Labeling, CMC and more.

Qualifications

• Bachelor's Degree with at least 5 years of relevant experience in the pharmaceutical industry.
• Master's Degree with at least 2 years of relevant experience in pharmaceutical industry.
• MD/PhD or other related doctoral degree in biological science, chemistry or related discipline with relevant experience.

Responsibilities

• Assist regulatory agency communications and submissions, including marketing applications, INDs, pediatric plans and reports.
• Develop and implement global regulatory strategy and background packages for submissions.
• Communicate with agencies and attend agency meetings to support the global regulatory lead.
• Collaborate with Regulatory Operations, Clinical Safety, Labeling, CMC and other functions on regulatory strategy.
• Research guidelines and competitive intelligence to inform regulatory strategy and author key strategy documents.
• Support life cycle management and label development across oncology programs.

Skills

Regulatory strategy

Regulatory submissions

Regulatory communications

Project management

Analytical skills

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in scientific field

Master's degree in scientific field

MD/PhD or related doctoral degree

Job description

Merck & Co., Inc. is seeking an Associate Director, Regulatory Affairs to support oncology products within a global regulatory framework.

The role emphasizes collaboration with the global regulatory lead on strategy development, regulatory submissions, and lifecycle management across programs. The candidate will contribute to regulatory science, communicate with agencies, and coordinate with cross-functional teams including Clinical Safety, Labeling, CMC and more.