Manager, Regulatory Affairs

West Pharmaceutical Services • Uwchlan Township, PA

1d • Hybrid

About The Position

In this role, you will be responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory approval, and preparing global regulatory submissions. This role ensures timely and high-quality execution of all regulatory deliverables. In addition, this role mentors team members, and provides support for global regulatory approvals, and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position includes supporting internal and external customer regulatory requests.

Requirements

• Bachelor's Degree science, math, engineering, computer science or related discipline required
• Minimum 8 years related work experience required
• Excellent oral communication and technical writing skills
• Advanced knowledge of product life cycle, product development, design control and change control.
• Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required.
• Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance.

Nice To Haves

• Master's Degree science, math, engineering, computer science or related discipline preferred
• PhD science, math, engineering, computer science or related discipline preferred
• Software in Medical Device or Software as Medical Device related work experience preferred
• Other Medical device or Combination Product regulatory experience preferred
• History of successful US 510(k) or PMA or device and EU Technical Documentation submissions.
• Pharmaceutical and Medicine\Regulatory Affairs Certifications (RAC)-RAPS Upon Hire preferred

Responsibilities

• Develop and implement regulatory strategies with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in the most efficient, compliant manner.
• Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals.
• Prepare Regulatory Assessments for proposed changes, concluding with sound regulatory strategies.
• Work with global Regulatory Affairs colleagues, Quality Assurance, and Research and Development teams to ensure submissions are accurately prepared and comply with global regulations.
• Prepare domestic and international submissions for products, to ensure timely approvals for market release.
• Provide guidance and leadership to cross functional teams for regulatory issues and questions.
• Provide technical review of data, reports, and labeling intended for regulatory submissions to ensure scientific rigor, accuracy, clarity of presentation, and compliance with applicable regulatory requirements.
• Review applicable new and updated applicable domestic and international regulations and guidance documents and assess the impact they may have to West products.
• Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to team and RA management.
• Other duties as assigned.

Benefits

• Community Involvement: West encourages volunteerism through its West without Borders initiative and other charitable programs that make a difference in local communities.
• Continuous Learning & Development: Opportunities for professional growth through training programs, tuition assistance, leadership development, and skill-certification initiatives.
• Generous Paid Time Off (PTO):
• Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work-life balance and recharge effectively.
• Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where all voices are heard and respected in a supportive environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager