Oncology Regulatory Strategy Lead

MSD Malaysia; North Wales (Montgomery County); Hybrid; USD 129,000 - 203,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays

Vacation

Sick days

Job summary

Merck & Co., Inc. seeks an Associate Director, Regulatory Affairs to support Oncology products within a regulatory team.

You will work with global regulatory leads to help develop and implement a global strategy for registration and maintenance of products. You will assist with submissions, strategy documents, and cross-functional collaboration to ensure compliant, timely regulatory outcomes across markets.

Qualifications

• Experience in drug development and regulatory submissions.
• Strong communication and collaboration across global teams.
• Proven ability to manage complex regulatory strategies for oncology products.
• Ability to interpret regulatory guidance and competitive intelligence.
• Experience with global regulatory agencies and submissions.

Responsibilities

• Assist in regulatory agency communications and submissions across markets.
• Draft, shepherd and review responses to Agency requests and background packages.
• Support development of global regulatory strategy and lifecycle management.
• Collaborate with Regulatory Operations, Clinical Safety, Labeling, and CMC teams.
• Contribute to process improvements and regulatory administrative activities.

Skills

Drug development experience

Regulatory submissions

Cross-functional collaboration

Excellent communication

Global regulatory strategy

Education

Bachelor’s Degree

Master’s Degree

MD/PhD or related doctoral degree

Job description

Merck & Co., Inc. seeks an Associate Director, Regulatory Affairs to support Oncology products within a regulatory team.

You will work with global regulatory leads to help develop and implement a global strategy for registration and maintenance of products. You will assist with submissions, strategy documents, and cross-functional collaboration to ensure compliant, timely regulatory outcomes across markets.