Senior Manager, Regulatory Affairs

Title:

Senior Manager, Regulatory Affairs

Requisition

Location:

Exton, PA, US, 19341

Department:
Regulatory Affairs

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

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.

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

In this role, you will be responsible for designing, optimizing, and overseeing the end‑to‑end business processes that support the delivery of contract regulatory services. You will ensure that regulatory service operations are efficient, scalable, compliant, and aligned with evolving global regulatory expectations and customer needs. This role serves as a key bridge between regulatory experts, quality, commercial teams, and external clients to enable consistent, high‑quality execution of contracted regulatory deliverables.

You must proactively maintain an understanding of health authority guidelines, regulations, and best practice to establish regulatory strategy.

• Lead the development, standardization, and continuous improvement of business processes supporting contract regulatory services (e.g. submission support, technical documentation, advisory services). Ensure those processes support high‑quality regulatory outputs.
• Interface with clients to understand requirements, define scope, and ensure processes deliver against contractual obligations.
• Map and manage end‑to‑end workflows, ensuring efficiency, scalability, and alignment with regulatory requirements.
• Support onboarding of new services, customers, and regulatory requirements into operational workflows.
• Establish and monitor KPIs (e.g. cycle time, quality metrics, client satisfaction) to identify process gaps, risks, and inefficiencies; implement improvements using data‑driven and risk‑based approaches.
• Partner with subject matter experts to translate regulatory requirements into standardized and repeatable service offerings.
• Work closely with Regulatory Affairs, Quality Assurance, Commercial, Legal, and IT teams to ensure seamless execution of services in line with business strategy and objectives.
• Identify and qualify vendors, tools, templates and systems to build efficiency.
• Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
• Other duties as assigned.

• Bachelor’s degree in science, math, engineering, or related discipline required with a minimum 10 years of experience.
• PhD / Master’s degree in science, math, engineering, or related discipline required with a minimum 5 years of regulatory/pharmaceutical experience.

• Excellent interpersonal, communication and listening skills.
• Experience in medical device regulatory affairs and/or design control process, direct interactions with regulatory agencies and management of regulatory support systems.
• Regulatory compliance competency including Quality Systems.
• International regulatory competency.
• Advanced degree.
• Regulatory Affairs Certification (R.A.C).
• Able to comply with the company’s safety and quality policies at all times.

• Strong collaborator and communicator, experienced engaging with and presenting to cross‑functional teams, customers, and industry stakeholders.
• Demonstrated technical leadership with broad understanding of pharmaceutical/biologic operations, device development, and combination products.
• Skilled in negotiation, decision‑making, and managing multiple…