Hiring: Sr Specialist, Regulatory Operations Company: West Pharmaceutical Services Location: Exton, PA Job Posted Time: 2026-09-16 16:02:08 Employment Type: Hybrid Target Skills & Keywords : Microsoft Excel, Microsoft Office, Microsoft PowerPoint, R About the job Experience: •Minimum 5 years of regulatory pharmaceutical or medical device experience OR Master’s degree in relevant discipline with minimum 1 year regulatory experience Required Skills: •This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. •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. •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 Qualifications: •Bachelor’s degree in a scientific or technical discipline OR equivalent experience •Hands-on experience preparing, reviewing, and formatting documentation for global regulatory submissions •Solid functional working knowledge of global regulatory submission standards (U.S., EU, China, ROW) •In-depth knowledge of documentation control and compliance processes •High attention to detail with strong planning and organizational skills •Demonstrated capacity 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 Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!