Senior Specialist, Regulatory Operations

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Requisition

Date:
Jul 21, 2026

Location:

Exton, PA, US, 19341

Department:
Regulatory Affairs

Description:

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week.

Who We Are:

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life‑saving and life‑enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun.

A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

The Sr. Specialist, Regulatory Affairs is responsible for the publishing, formatting, and maintenance of regulatory documentation supporting West’s global product portfolios. This role ensures regulatory submissions are prepared accurately and in compliance with applicable global health authority requirements. This position operates independently on assigned regulatory projects, collaborates cross-functionally, and escalates regulatory risks appropriately to Regulatory Affairs leadership. The role focuses on high-quality execution, compliance, and continuous improvement within established regulatory frameworks.

• Publish, format, and maintain regulatory submissions (DMFs, Dossiers, MAFs, 510(k) s, and related filings) in alignment with global regulatory requirements
• Compile and prepare electronic submission packages according to regional health authority guidelines and internal standards
• Retrieve, organize, and provide regulatory documentation in response to customer and agency requests
• Perform compliance reviews of assigned technical documentation, certifications, and correspondence to ensure completeness, accuracy, and adherence to regulatory requirements
• Maintain organized and secure shared regulatory platforms to support collaboration with customers, consultants, and regulatory bodies
• Partner with R&D, Quality, Operations, and Commercial teams to gather required submission documentation and ensure alignment to project timelines
• Communicate project status, milestones, and potential issues clearly to stakeholders; escalates regulatory risks and concerns appropriately to RA management
• Adapt effectively to evolving regulatory requirements and changing project priorities
• Identify and support implementation of process improvements within assigned regulatory operations to enhance efficiency and documentation quality
• Support Lean Sigma initiatives and continuous improvement efforts within the Regulatory Affairs function
• Perform other duties as assigned

• Bachelor’s degree in a scientific or technical discipline OR equivalent experience

• Minimum 5 years of regulatory pharmaceutical or medical device experience OR
• Master’s degree in relevant discipline with minimum 1 year regulatory experience

• Hands‑on experience preparing, reviewing, and formatting documentation for global regulatory submissions
• Working knowledge of global regulatory submission standards (U.S., EU, China, ROW)
• Strong understanding of documentation control and compliance processes
• High attention to detail with strong planning and organizational skills
• Ability to manage multiple concurrent assignments and deadlines independently
• Proficiency in Microsoft Office (Excel, Word, PowerPoint) and Adobe Acrobat
• Builds effective working relationships across…