Global Regulatory Lead, Immunology (Remote)

MSD Malaysia; Rahway (NJ); On-site; USD 191,000 - 300,000; Full time

Benefits offered by this job

Comprehensive benefits

401(k) retirement plan

Job summary

Merck & Co., Inc. in Rahway, NJ, seeks a Senior Director (Sr.

Principal Scientist), Regulatory Affairs Liaison to craft and execute worldwide regulatory strategies for General Medicine, with a focus on Immunology development programs. You will serve as the global single point of contact on project teams and independently interact with regulatory agencies to align strategy and registration requirements across indications and formulations.

Qualifications

• B.S. or M.S. with ≥10 years in drug development, majority in regulatory.
• M.D./Ph.D./PharmD with ≥7 years in drug development and ≥5 years in regulatory.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and speed approvals.
• Leads the Global Regulatory Team and coordinates cross-functional regulatory support.
• Interacts with major health authorities (FDA, EMA) and regulatory agencies worldwide.
• Prepares IND/CTAs and global submissions for developmental drugs/biologics.
• Leads regulatory meetings and prepares for FDA advisory committees as applicable.

Skills

Regulatory strategy

Global regulatory

Strategic leadership

Stakeholder management

Regulatory communications

Education

B.S. or M.S in a relevant field

M.D./Ph.D./PharmD in a relevant field

Job description

Merck & Co., Inc. in Rahway, NJ, seeks a Senior Director (Sr.

Principal Scientist), Regulatory Affairs Liaison to craft and execute worldwide regulatory strategies for General Medicine, with a focus on Immunology development programs. You will serve as the global single point of contact on project teams and independently interact with regulatory agencies to align strategy and registration requirements across indications and formulations.