Regulatory Affairs & BD Strategy Lead

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

Benefits offered by this job

Medical, Dental, Vision coverage

401(k) retirement plan

Paid holidays

Sick days

Job summary

Merck is seeking a lead for Global Regulatory Affairs and Clinical Safety (GRACS) to manage regulatory and contract activities for business development transactions, including due diligence, drafting and negotiating master and regulatory agreements, and coordinating cross-functional implementation teams.

The role collaborates with BD, Clinical Research, Legal, and Alliance Management, and requires managing deal-specific GRACS implementation teams and ongoing partner diligence.

Qualifications

• Bachelor's degree required.
• Experience in regulatory affairs, BD, and contracting.
• Strong project management and coordination skills.
• Familiarity with FDA regulations and cross-functional collaboration.

Responsibilities

• Lead GRACS activities across business development lifecycle (strategy, evaluation, due diligence, contracting, implementation).
• Draft, negotiate, and maintain master and regulatory agreements and amendments.
• Coordinate due diligence, assemble cross-functional teams, and manage implementation plans.

Skills

Adaptability

Agreement Management

Budget Management

Business Development

Cross-Functional Project Management

FDA Regulations

Pharmacovigilance

Policy Implementation

Project Management

Education

Bachelor's Degree

Job description

Merck is seeking a lead for Global Regulatory Affairs and Clinical Safety (GRACS) to manage regulatory and contract activities for business development transactions, including due diligence, drafting and negotiating master and regulatory agreements, and coordinating cross-functional implementation teams.

The role collaborates with BD, Clinical Research, Legal, and Alliance Management, and requires managing deal-specific GRACS implementation teams and ongoing partner diligence.