Sr Specialist, Regulatory Operations

RXinsider LTD.; Exton, Northern (PA, KY); Hybrid; USD 95,000 - 135,000; Full time

Job summary

West Pharmaceutical Services is seeking a Sr. Specialist in Regulatory Affairs to manage publishing, formatting, and maintenance of regulatory documents for global portfolios.

The role requires independence on projects, cross-functional collaboration, and a focus on compliance and continuous improvement. The position involves staying current with evolving regulatory requirements, coordinating with R&D, Quality, and Operations, and ensuring timely submission milestones.

Qualifications

• 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 with minimum 1 year regulatory experience.
• Working knowledge of global regulatory submission standards (U.S., EU, China, ROW) and documentation control processes.

Responsibilities

• Publish, format, and maintain regulatory submissions (DMFs, Dossiers, MAFs, 510(k)s, and related filings) in alignment with global regulatory requirements.
• Prepare electronic submission packages according to regional guidelines and internal standards.
• Coordinate and retrieve regulatory documentation in response to customer and agency requests.
• Support compliance reviews of technical documentation to ensure regulatory readiness.
• Collaborate with R&D, Quality, Operations, and Commercial teams to gather submission materials and align with timelines.
• Communicate project status and escalate risks to RA leadership.
• Assist in implementing process improvements within regulatory operations.

Skills

Regulatory submissions

Documentation control

Cross-functional collaboration

Attention to detail

Project management

Education

Bachelor's degree in science/engineering

Master's degree (preferred)

Tools

Microsoft Office

Adobe Acrobat

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

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.

Essential Duties And Responsibilities

• 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

Education

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

Work Experience

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

Preferred Knowledge, Skills And Abilities

• 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 global, cross-functional teams
• Shares information clearly and supports team objectives
• Maintains high standards of accuracy and regulatory rigor
• Adheres consistently to SOPs, regulatory requirements, and company quality policies
• Adjusts effectively to changing priorities and regulatory updatesMaintains performance during periods of change
• Proactively identifies opportunities to improve assigned processes
• Supports implementation of approved improvements within the function
• Takes ownership of assigned deliverables and timelines
• Demonstrates reliability and follow-through in a deadline-driven environment
• Able to comply with the company's safety policy at all times
• Able to comply with the company's quality policy at all times

Travel Requirements

5%: Up to 13 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.

Additional Requirements

• Must be able to communicate effectively, speak in front of groups, express & exchange ideas and understand direction.
• Maintain the ability to work well with others in a variety of situations.
• Able to multi-task, work under time constraints, problem solve, and prioritize.
• Able to learn and apply new information or new skills.
• Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company)

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.