Senior Manager, Regulatory Affairs

West Pharmaceutical Services; Exton (PA); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Performance-based bonuses

Volunteer opportunities

Employee recognition programs

Job summary

JobRx, Inc. is hiring for a hybrid position focused on designing and optimizing regulatory service processes. You will ensure compliance and efficiency while serving as a vital link between teams.

Preferred candidates have a minimum of 10 years in the field and a strong background in regulatory affairs. The role offers opportunities for cross-team collaboration and technical leadership, with a commitment to inclusivity and community involvement.

Qualifications

• Minimum 10 years of experience in a related field.
• Minimum 5 years of regulatory/pharmaceutical experience for advanced degrees.

Responsibilities

• Design and optimize business processes for regulatory services.
• Interface with clients to define scope and requirements.
• Establish KPIs and implement improvements.

Skills

Excellent interpersonal skills

Medical device regulatory affairs experience

Regulatory compliance competency

International regulatory competency

Pharmaceutical/biologic operations understanding

Education

Bachelor’s degree in science, math, engineering

Ph.D./Master’s in related discipline

Job 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 connected by a purpose to improve patient lives. Founded when Herman O. West supplied penicillin during World War II, we deliver injectable medicines worldwide.

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.
• 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.

Equal Opportunity Employer

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. If you have a special need that requires accommodation in order to apply to West, please send an email to [e-mail]. 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.