Senior Regulatory Affairs Manager - Submissions & Compliance

Paycom - ATS; Waunakee (WI); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Competitive compensation

Day 1 benefits: Medical, Dental and V"

Life & AD&D Insurance

Short and Long-term Disability

Health and Flexible Spending Account

Employee Assistance Program

Generous vacation

Paid Holidays

401k

Advancement opportunities

Job summary

Scientific Protein Laboratories (SPL) in Waunakee, WI, is seeking a Sr Regulatory Affairs Manager to lead regulatory submissions, develop regulatory strategies, and coordinate with cross-functional teams to ensure compliance across FDA, EMA, and ICH guidelines.

The role emphasizes preparing DMFs, INDs, NDAs, and other regulatory filings, maintaining lifecycle management, and providing strategic regulatory expertise for global product approvals and post-approval changes.

Qualifications

• Bachelor’s Degree or above in a Scientific discipline required; Graduate Level Degree preferred.
• RAC-Drugs (Regulatory Affairs Certification) certification required.
• Experience with active pharmaceutical ingredient master files (APIMF).
• Experience with biologics, process variabilities, and CMC manufacturing controls.
• Experience with stability studies and change control assessments for regulatory filings.
• Familiarity with USDA and related import/export regulations.

Responsibilities

• Manage Regulatory Submissions—prepare, submit, and lifecycle manage DMFs, INDs, NDAs, BLAs, ANDAs, and CTAs.
• Support client global filing strategies and compile CMC sections as needed.
• Assess regulatory pathways and ensure compliance with FDA, EMA, ICH, and other regulations.
• Maintain compliance by monitoring regulatory changes and updating processes accordingly.
• Coordinate with quality, manufacturing, R&D, and supply chain to meet timelines and requirements.
• Serve as regulatory liaison with clients and respond to agency inquiries.

Education

Bachelor’s Degree in a Scientific discipline

Graduate Level Degree in a Scientific discipline

Job description

Scientific Protein Laboratories (SPL) in Waunakee, WI, is seeking a Sr Regulatory Affairs Manager to lead regulatory submissions, develop regulatory strategies, and coordinate with cross-functional teams to ensure compliance across FDA, EMA, and ICH guidelines.

The role emphasizes preparing DMFs, INDs, NDAs, and other regulatory filings, maintaining lifecycle management, and providing strategic regulatory expertise for global product approvals and post-approval changes.