US Regulatory Strategy Lead — Remote

Lundbeck; Oregon; Hybrid; USD 165,000 - 185,000; Full time

Benefits offered by this job

Flexible PTO

Health benefits (Medical, Dental, and

401(k) match

Long-term incentive plan

Job summary

Lundbeck in the United States is seeking a Senior Manager, Regulatory Strategy (US RA) to lead regulatory strategy and ensure successful US development and approval of drug/biologic products. You will work with cross-functional teams to align with FDA requirements and corporate standards while maintaining clear communications with partners.

The role requires extensive US RA experience, ability to navigate FDA processes, and a proactive approach to compliance and strategic planning.

Qualifications

• Accredited Bachelor's Degree in a science field.
• 7+ years in the pharmaceutical/biotech industry.
• 5+ years US Regulatory Affairs experience.
• Experience with US drug development and regulatory submissions.
• Strong regulatory writing and communication skills.
• Ability to work independently and in a matrix environment.

Responsibilities

• Provide regulatory review of documentation for FDA submissions and ensure accuracy and compliance.
• Serve as US subject matter expert to support strategy development and execution.
• Act as FDA contact and liaise with authorities for drug development and approvals.
• Manage regulatory submissions and ensure review/approval per requirements.
• Monitor external regulatory climate and inform stakeholders of impacts.
• Lead or assist in compliance improvements and departmental efficiencies.
• Prepare documentation for US FDA throughout product lifecycle.

Skills

Regulatory strategy

US Regulatory Affairs

Regulatory submissions

FDA regulations

Communication skills

Attention to detail

Multinational team

Problem solving

Education

Accredited Bachelor's Degree

Advanced degree in Science/Pharmacy

Chemistry/Pharmacy background

Tools

Regulatory EDMS

MS Word

MS Excel

Adobe Acrobat

Job description

Lundbeck in the United States is seeking a Senior Manager, Regulatory Strategy (US RA) to lead regulatory strategy and ensure successful US development and approval of drug/biologic products. You will work with cross-functional teams to align with FDA requirements and corporate standards while maintaining clear communications with partners.

The role requires extensive US RA experience, ability to navigate FDA processes, and a proactive approach to compliance and strategic planning.