Hybrid Senior Regulatory Affairs Specialist

West Pharmaceutical Services / Progressive Medical; Exton (PA); Hybrid; USD 120,000 - 150,000; Full time

Job summary

West Pharmaceutical Services seeks a regulatory professional to coordinate, author and manage material compliance for parenteral packaging, device and contract manufacturing portfolios. With minimal support, you will ensure timely regulatory deliverables and compliance with US and international requirements, focusing on environmental regulations.

This role supports material change controls, regulatory inquiries, R&D product development, and maintains knowledge of current regulations.

Qualifications

• Bachelor's degree or higher in a science/engineering field or equivalent experience.
• 5+ years in regulatory, product stewardship or environmental regulations.
• Knowledge of global pharma/medical device regulations and environmental policies.
• Strong communication and project leadership abilities.

Responsibilities

• Coordinate, author and manage material regulatory compliance for product portfolios.
• Submit regulatory reports and respond to regulatory inquiries in timely fashion.
• Develop compliant processes and establish user requirements for tools.
• Mentor teammates and provide regulatory guidance to cross-functional teams.
• Monitor and interpret global regulations and maintain training on procedures.

Skills

Regulatory knowledge

Environmental regulations

Regulatory reporting

Cross-functional communication

Education

Bachelor's/Master's/PhD in science or engineering

Tools

MS Word

MS Excel

MS Teams

PowerPoint

Master Control

SharePoint

Job description

West Pharmaceutical Services seeks a regulatory professional to coordinate, author and manage material compliance for parenteral packaging, device and contract manufacturing portfolios. With minimal support, you will ensure timely regulatory deliverables and compliance with US and international requirements, focusing on environmental regulations.

This role supports material change controls, regulatory inquiries, R&D product development, and maintains knowledge of current regulations.