Senior Regulatory Affairs Lead – Hybrid & Global Compliance

West Pharmaceutical Services, Inc; Dublin; Hybrid; EUR 60,000 - 76,000; Full time

Benefits offered by this job

Hybrid work model

Comprehensive benefits

Paid time off

Job summary

West Pharmaceutical Services, Inc. seeks a Senior Regulatory Affairs Specialist to coordinate, author, and manage material compliance for parenteral packaging, device, and contract manufacturing portfolios.

The role ensures timely regulatory deliverables and compliance with US and international requirements, focusing on environmental regulations. Located in Dublin with a hybrid schedule (onsite 3 days/week).

Qualifications

• Minimum 5 years of experience in Regulatory, Product Stewardship, Environmental Regulations or equivalent.
• Experience with global regulatory environments (US/EU/Rest of World).
• Strong communication and collaboration skills.
• Ability to mentor team members and train others.

Responsibilities

• Drive material compliance to applicable global product and/or packaging regulatory/environmental legislations for West's product portfolios.
• Manage and submit regulatory reports in accordance with applicable regulations and reporting deadlines.
• Communicate with West's suppliers requesting documentation and/or questionnaires to support compliance with applicable regulations and customer inquiries.
• With minimal support, develop compliance process including establishment of user requirements for tools supporting compliance process where applicable.
• Manage change controls and/or changes to supplier material compliance information and determine impact for West.
• Monitor regulations, legislations and policies and provide regulatory guidance and communicate regulatory progress, decisions, strategies to cross functional teams.

Skills

Regulatory leadership

Self-motivation

Communication

Problem solving

Team mentorship

Education

Science/Engineering degree

Tools

MS Word

MS Excel

MS Teams

MS PowerPoint

MasterControl

Adobe

SharePoint

Job description

West Pharmaceutical Services, Inc. seeks a Senior Regulatory Affairs Specialist to coordinate, author, and manage material compliance for parenteral packaging, device, and contract manufacturing portfolios.

The role ensures timely regulatory deliverables and compliance with US and international requirements, focusing on environmental regulations. Located in Dublin with a hybrid schedule (onsite 3 days/week).