Senior Manager, Regulatory Affairs

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Requisition

Date:
Sep 22, 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.

No relocation is provided for this opportunity.

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 Senior Manager, Regulatory Affairs serves as a strategic leader within the Global Regulatory Affairs organization and is responsible for regulatory publishing strategy, people leadership, and hands-on oversight of complex publishing and submission activities across West’s product portfolio.
• This role partners closely with cross-functional and global regulatory teams to ensure the timely, accurate, and compliant preparation, formatting, compilation, publishing, and maintenance of regulatory documentation for submissions to health authorities in the United States, European Union, China, and Rest of World.
• The Senior Manager is expected to lead and develop team capabilities, drive process excellence, and remain closely involved in critical publishing operations to ensure high-quality execution, regulatory compliance, and successful submission outcomes.

• Lead the global regulatory publishing strategy and execution for West's product portfolios, ensuring regulatory submissions are prepared, formatted, compiled, published, and transmitted in compliance with applicable regulations, guidelines, and internal procedures.
• Oversee the publishing and lifecycle management of regulatory documentation, including CMC dossiers, DMFs, MAFs, 510(k) s, LOAs, and other submissions for health authorities in the U.S., EU, China, and Rest of World, while maintaining hands-on involvement in complex or high-priority publishing activities.
• Lead, develop, and manage regulatory publishing personnel by setting priorities, providing coaching and mentorship, and ensuring high-quality, timely execution of deliverables aligned with business objectives and submission timelines.
• Partner with global Regulatory Affairs colleagues and cross-functional stakeholders to ensure submission content and supporting documentation are complete, well organized, scientifically accurate, and suitable for regulatory review and acceptance.
• Oversee and continuously improve regulatory publishing processes, systems, documentation practices, and operational workflows to enhance efficiency, consistency, traceability, quality, and compliance.
• Monitor changes in the global regulatory environment, assess potential impact on publishing operations and submission standards, and provide guidance to internal stakeholders on regulatory publishing requirements and…