Regulatory Affairs Lead, Material Compliance (Hybrid)

West Pharmaceutical Services, Inc; Exton (PA); Hybrid; USD 110,000 - 150,000; Full time

Job summary

West Pharmaceutical Services, Inc. is seeking a Senior Regulatory Affairs Specialist in Exton, PA for a hybrid role requiring onsite presence at least 3 days per week.

The role focuses on coordinating, authoring, and managing material compliance across parenteral packaging, device, and contract manufacturing portfolios. The candidate will ensure timely delivery of regulatory deliverables, maintain knowledge of US and international regulations, mentor teammates, and provide training within the

Qualifications

• Bachelor's, Master's or PhD in science, math, engineering, or equivalent experience.
• Minimum 5 years of Regulatory, Product Stewardship, Environmental Regulations or equivalent.
• Experience coordinating and managing regulatory deliverables.
• Knowledge of US and international regulations/guidelines for pharma/medical devices.
• Strong communication and cross-functional collaboration skills.
• Ability to work hybrid onsite and adapt to changing priorities.

Responsibilities

• Drive material compliance to applicable global product and/or packaging regulatory/environmental legislations for West's portfolios.
• Manage and submit regulatory reports in accordance with regulations and deadlines.
• Coordinate with suppliers requesting documentation for regulatory compliance and customer inquiries.
• Develop compliance processes including user requirements for tools supporting compliance.
• Manage change controls and assess impact of changes to supplier material compliance information.
• Mentor team members and provide training to internal RA staff.

Skills

Regulatory Reporting

Change Control

Regulatory Affairs

Regulatory Strategy

Education

Bachelor's in science

Master's/PhD in science

Tools

Master Control

MS Excel

SharePoint

MS Word

Job description

West Pharmaceutical Services, Inc. is seeking a Senior Regulatory Affairs Specialist in Exton, PA for a hybrid role requiring onsite presence at least 3 days per week.

The role focuses on coordinating, authoring, and managing material compliance across parenteral packaging, device, and contract manufacturing portfolios. The candidate will ensure timely delivery of regulatory deliverables, maintain knowledge of US and international regulations, mentor teammates, and provide training within the