Senior Regulatory Affairs Manager - Global Submissions Lead

Scientific Protein Laboratories, LLC; Madison (WI); Sur place; USD 120 000 - 180 000; Plein temps

Avantages offerts par ce poste

Medical benefits

Dental and Vision on Day 1

Life Insurance & AD&D

Disability (Short and Long-term)

401k

Résumé du poste

Scientific Protein Laboratories, LLC (SPL) is seeking a Senior Regulatory Affairs Manager to lead regulatory strategy and submissions for biosourced APIs. You will advise QA and management, coordinate cross-functional teams, and drive timely submissions to global authorities.

The role requires RAC certification and deep experience with APIMF, CMC controls, and post-approval changes to support continuous supply and compliance across markets.

Qualifications

• Bachelor’s degree or higher in a scientific discipline required.
• 5+ years in regulatory affairs; 10+ years preferred, RAC certification is desired.
• Experience with APIMF, biologics, CMC controls, and stability studies.
• Knowledge of FDA, EMA, ICH guidelines, with experience in submissions and DMFs.

Responsabilités

• Prepare, submit, and manage regulatory filings including DMFs, INDs, NDAs, BLAs, ANDAs, and CTAs.
• Coordinate regulatory submissions with QA, manufacturing, R&D, and supply chain.
• Identify regulatory pathways and ensure compliance across markets.
• Maintain compliance with evolving guidelines and data integrity principles.
• Serve as regulatory liaison with clients and health authorities.
• Lead post-approval changes, variations, and commitments.

Connaissances

Regulatory submissions

RAC Certification

APIMF experience

Biologics experience

Change control

Stability studies

USDA import/export

Data integrity

Cross-functional collaboration

Formation

Bachelor's degree in sciences

Graduate degree preferred

Description du poste

Scientific Protein Laboratories, LLC (SPL) is seeking a Senior Regulatory Affairs Manager to lead regulatory strategy and submissions for biosourced APIs. You will advise QA and management, coordinate cross-functional teams, and drive timely submissions to global authorities.

The role requires RAC certification and deep experience with APIMF, CMC controls, and post-approval changes to support continuous supply and compliance across markets.