Senior Regulatory Strategy Lead (US) — Remote

Lundbeck; Boston (MA); Hybrid; USD 165,000 - 185,000; Full time

Benefits offered by this job

PTO

Health benefits (Medical, Dental, VIs)

401k match

Job summary

Lundbeck is seeking a Senior Manager, Regulatory Strategy (US RA) to design and implement regulatory strategies for US drug development and approvals. You will partner with Global Regulatory Lead and RA teams to ensure FDA alignment and lifecycle management across product programs.

The role involves leading FDA submissions, monitoring regulatory changes, and guiding cross-functional teams to meet timelines while ensuring compliance and quality.

Qualifications

• Accredited Bachelor's Degree required.
• 7+ years in pharma/biotech industry.
• 5+ years US Regulatory Affairs experience.
• Direct experience with US drug development and regulatory submissions.
• Strong understanding of laws/regulations for drugs/biologics.

Responsibilities

• Provide regulatory review of documents for FDA submissions.
• Serve as US regulatory SME to support strategy development.
• Liaise with authorities for drug development and approvals.
• Monitor regulatory climate for impact on objectives.
• Assist or lead compliance improvements and efficiencies.
• Prepare documentation for US FDA submissions throughout lifecycle.
• Advise on regulatory requirements for clinical studies and labeling.
• Develop strategies with contingencies and alternative approaches.
• Work independently and within cross-functional teams.

Skills

US regulatory strategy

FDA regulations

Regulatory submissions

Regulatory risk assessment

Attention to detail

Multitasking

Communication skills

Independent work

Cross-functional teamwork

Regulatory guidance interpretation

Education

Accredited Bachelor's Degree

Bachelor’s in Science/Chemistry/Pharmacy

Advanced Degree in Science/Chemistry/Pharmacy

Tools

MS Word

MS Excel

Adobe Acrobat

Regulatory EDMS

Job description

Lundbeck is seeking a Senior Manager, Regulatory Strategy (US RA) to design and implement regulatory strategies for US drug development and approvals. You will partner with Global Regulatory Lead and RA teams to ensure FDA alignment and lifecycle management across product programs.

The role involves leading FDA submissions, monitoring regulatory changes, and guiding cross-functional teams to meet timelines while ensuring compliance and quality.