Global Regulatory Affairs Lead (Hybrid)

RXinsider LTD.; Exton (PA); Hybrid; USD 110,000 - 160,000; Full time

Job summary

West Pharmaceutical Services in Exton, PA, is seeking a Regulatory Materials Compliance professional to coord, author, and manage regulatory and environmental compliance for parenteral packaging, device, and contract manufacturing portfolios. The role focuses on timely, high‑quality deliverables and adherence to US and international guidelines.

You will mentor team members, support change controls, respond to regulatory inquiries, and provide data for submissions to North America, Europe, and

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.
• Ability to work in a hybrid on-site environment with a minimum of 3 days per week on-site.

Responsibilities

• Drive material compliance to global product/packaging regulatory and environmental laws.
• Manage and submit regulatory reports per applicable regulations and deadlines.
• Coordinate with suppliers to obtain documentation and questionnaires for compliance.
• Develop compliance processes and tool requirements with minimal support.
• Manage change controls and assess impact on regulatory information.
• Monitor regulations and provide guidance and progress updates to cross‑functional teams.
• Provide product compliance data for regulatory submissions to NA, Europe and RoW.
• Mentor team members and provide training to internal staff.
• Communicate project status to RA management and stakeholders.
• Other duties as assigned.

Skills

Regulatory leadership

Regulatory knowledge

Communication

Organizational skills

Problem solving

Education

Bachelor's/Master's/PhD in science, engineering or related field

Tools

MS Word

MS Excel

MS Teams

MS PowerPoint

Master Control

Adobe

SharePoint

Job description

West Pharmaceutical Services in Exton, PA, is seeking a Regulatory Materials Compliance professional to coord, author, and manage regulatory and environmental compliance for parenteral packaging, device, and contract manufacturing portfolios. The role focuses on timely, high‑quality deliverables and adherence to US and international guidelines.

You will mentor team members, support change controls, respond to regulatory inquiries, and provide data for submissions to North America, Europe, and