Senior Specialist, Regulatory Affairs

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per weekNo relocation is provided for this opportunityWho 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 SummaryThe Senior Specialist, Regulatory Affairs is expected to understand development of medical devices as applicable to combination products. To ensure, with minimal supervision, regulatory strategies are applied to regulatory submission documents to meet program requirements including Premarket Notifications, Global Registrations, Technical Documentation for CE Marking or those associated with NDAs, BLAs, MAAs. In addition, the Sr. Specialist ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position includes supporting internal and external customer regulatory requests.Essential Duties and ResponsibilitiesImplement regulatory strategies for medical devices and combination products with an emphasis on gaining regional regulatory approval/clearance/licensePrepare US, EU, and international submission sections (510k, IND, CTA, IMPD, NDA, BLA, MAA, etc.) for new products, product changes and information requests as required to ensure timely approvals for clinical studies and market release throughout the product life-cycleAuthor and review product submissions and assist with submission strategy and issues with regulatory bodiesProvide guidance to global cross-functional teams to ensure documentation is accurately prepared with consideration to scientific rigor, accuracy, and clarity of presentation to support high quality global regulatory submissionsReview change controls to determine impact and reportability to existing regulatory filingsSupports EU RA office with complaints and Post Market Surveillance of marketed productsMaintain proficiency in worldwide regulatory requirements and establish and maintain good working relationships with agency personnelDevelop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goalsOther duties as assignedEducationBachelor's Degree in science, math, engineering, or related discipline required orMaster's Degree in science, math, engineering, or related discipline preferred orPhD in science, math, engineering, or related discipline preferred orAdvanced degree preferredWork ExperienceMinimum 5 years of experience with Bachelor’s degree orMinimum 2 years of experience with Master’s degree/PhD in medical device regulatory required Preferred Knowledge, Skills and AbilitiesUS Class II and EU Class IIa device experience and knowledge of US FDA regulations (Title 21), EU MDD (93/42/EEC) and MDR (2017/745), 21 CFR 820, 210, 211 and ISO 13485Knowledge of drug / device combination product global regulations and guidance’sUnderstanding of product life cycle, product development process, design control and change controlExperience with interactions with government agenciesPossesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance)Strong negotiation and decision-making skillsExcellent oral communication and technical writing skillsExperience with combination product delivery systemsAble to comply with the company’s safety policy at all timesAble to comply with the company’s quality policy at all times #LI-NJ1 #LI-hybridLicense and CertificationsRegulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferredTravel Requirements5%: Up to 13 business days per yearPhysical RequirementsSedentary-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 RequirementsAbility to work in sedentary environment, in an office; may need to stand or sit for extended periods of timeAbility to communicate effectively, speak in front of groups, express & exchange ideas and understand directionAbility to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teamsAbility to review, collate, describe, and summarize scientific and technical data. Ability to organize complex information and combine pieces of information to form general rules or conclusionsAbility to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitmentsAbility to be flexible with changing priorities and comply with constantly changing regulatory proceduresMaintain working knowledge of computer software packages including eCTD, MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint and others as requiredWest 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 View email address on job-api.jobget.com. 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.