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Title:  Specialist, Regulatory Affairs

Requisition ID:  60639
Date:  Sep 22, 2023

Exton, Pennsylvania, US

Department:  Regulatory Affairs



Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.


At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.


Job Summary:

In this role, you will, with as-needed supervision, coordinate and author regulatory submissions for West’s elastomer and CZ components products and processes. This position includes supporting internal and external customer regulatory requests and maintaining knowledge of the current US and international regulations/guidelines/policies applicable to West’s products and services.


Essential Duties and Responsibilities:

  • Complete moderately complex regulatory assignments with guidance in support of R&D and commercial programs with a focus on authoring, maintenance and tracking of CMC dossiers for submission to Health Authorities in compliance with regulations, guidelines, and procedures
  • Assess change controls, with guidance, for impact to regulatory filings and update filings as applicable
  • Participate on project development teams, review technical project documentation such as protocols, summary reports, regulatory plans, certifications, correspondences, and external communications, as needed, and provide guidance as applicable
  • Provide customers with West product-related information and data as required for regulatory submissions to global regulatory agencies
  • Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc
  • Interface and build relationships with West facilities to ensure regulatory filings reflect current processes
  • Provide FDA clearance information for importation of West products, as applicable
  • Challenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive change
  • Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance
  • Other duties as assigned


Basic Qualifications: 

  • Education: Bachelor's, Master's degree or PhD in science, math, engineering or related discipline or equivalent experience
  • Experience: 3-5 years; or master’s degree/PhD with 1+years


Preferred Knowledge, Skills, and Abilities:

  • Knowledge of CMC regulatory affairs and regulatory operations
  • Experience interacting with government agencies
  • Knowledge in submissions management and electronic publishing of CMC submissions to Global Health Related agencies
  • Hands-on experience in the process of generating, reviewing, and formatting documentation for worldwide regulatory submissions
  • Demonstrated ability to manage multiple tasks/projects/priorities simultaneously
  • Attention to detail with planning, time management and organizational skills
  • Self-motivated with a proactive attitude and the ability to work effectively
  • Excellent interpersonal, communication and technical writing skills
  • Ability to be an effectives team member and work well with others in a team environment on cross-functional teams
  • Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.

Travel Requirements:

  • Must be able to travel up to 5-10% of the time (meetings, trainings, projects, industry events), including international travel


Physical and Mental Requirements:

  • Sedentary environment: ability to work in an office; may need to stand or sit for extended periods of time
  • 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  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 and/or a pre-employment drug screening.

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