Senior Manager, Regulatory Affairs

RXinsider LTD.; Exton (PA); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Community involvement

Inclusive and collaborative culture

Performance-based bonuses

Job summary

West Pharmaceutical Services is seeking a regulatory operations leader for a hybrid role requiring onsite presence a minimum of 3 days per week. You will design, optimize, and oversee end‑to‑end business processes supporting contract regulatory services to ensure efficiency, compliance, and alignment with global guidelines.

Responsibilities include leading process standardization, client interface, and KPI-driven improvements while collaborating with Regulatory Affairs, QA, Commercial, Legal,

Qualifications

• 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.
• Regulatory Affairs Certification (R.A.C) preferred upon hire.

Responsibilities

• Lead the development, standardization, and continuous improvement of business processes supporting contract regulatory services.
• 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.
• Work closely with Regulatory Affairs, Quality Assurance, Commercial, Legal, and IT teams to ensure seamless execution of services.

Skills

Regulatory strategy

Stakeholder communication

Cross-functional leadership

Regulatory compliance

Education

Bachelor’s degree in science/engineering

PhD/Master’s in science/engineering

Job description

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.

Job Summary

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.

Essential Duties And Responsibilities

• 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.

Work Experience

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

Preferred Knowledge, Skills And Abilities

• 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

Additional Requirements

• 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 projects with competing priorities and timelines.
• Able to analyze and synthesize complex scientific, technical, and regulatory information to drive sound conclusions and actions.
• Self‑motivated, adaptable, and effective in fast‑paced environments, with solid organizational, problem‑solving, and documentation skills.

License and Certifications

• Pharmaceutical and Medicine\Regulatory Affairs Certifications (RAC)-RAPS Regulatory Affairs Certification (R.A.C) Upon Hire preferred

Travel Requirements

20%: Up to 52 business days per year

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

What We Offer

Community Involvement: West encourages volunteerism through its West without Borders initiative and other charitable programs that make a difference in local communities.

Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where all voices are heard and respected in a supportive environment.

Recognition & Rewards: Performance‑based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact.

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

Equal Opportunity Statement

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.

Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.