About this role
<p><span style="text-decoration:underline"><strong><span>This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week.</span> No relocation or visa sponsorship is provided for this opportunity.</strong></span></p> <p> </p> <p><strong>Who We Are:</strong></p> <p>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? </p> <p> </p> <p>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. </p> <p> </p> <p>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. </p><div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H4 style="font-size:1.0em;margin:0.0px"><b>Job Summary</b></H4> </div><div><ul> <li style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif">The Principal Regulatory Affairs Project Manager is responsible for leading complex, high‑visibility regulatory programs across West’s portfolio of medical devices, combination products, and packaging/containment systems. This includes driving regulatory strategies, execution, and compliance across global markets. </span></li> <li style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif">In this role, you will collaborate with and provide project management leadership to cross-functional teams to support global clinical and commercial regulatory initiatives, including the planning and submission of high-impact regulatory filings such as Premarket Notifications, EU MDR Technical Documentation, and Master Files (DMF/MAF) that support pharmaceutical partners’ INDs, NDAs, ANDAs, BLAs, and CTAs. </span></li> <li style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif">This role requires strong strategic thinking, the ability to manage competing priorities, and the leadership skills necessary to drive decision‑making across a complex, matrixed environment.</span></li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Essential Duties and Responsibilities</b></H2> </div><div><ul> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">With a high degree of autonomy, <strong>lead cross-functional regulatory project teams</strong> in the development and execution of global regulatory strategies across the product lifecycle, ensuring alignment with business objectives and evolving regulatory requirements.</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Drive end-to-end regulatory project execution for high-impact programs, from early development through post-market activities, ensuring timely delivery of key milestones, proactive <strong>risk management</strong>, and strategic decision-making.</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Direct the preparation and submission of complex regulatory dossiers, including initial submissions, amendments, and responses to information requests. Ensure submissions meet quality standards and regulatory expectations. Support submission authoring and reviewing as needed.</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Anticipate and manage regulatory risks for all business priorities, developing and implementing robust mitigation strategies. Lead resolution of complex regulatory issues and ensure timely escalation and closure.</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Provide technical and strategic input on global regulatory plans, change assessments and agency responses.</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Work closely with R&D, quality assurance, clinical affairs, and manufacturing teams to ensure regulatory strategy and considerations are integrated into product development and lifecycle management.</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Lead interactions with external customers, partners and regulatory agencies on pre-submissions, change notifications, audits and information request responses, as required, to fulfill business objectives.</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Drive continuous improvement initiatives within the regulatory function, including the development and implementation of advanced project management tools, performance dashboards, and knowledge-sharing platforms.</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Optimize RA databases for information requests, submissions and integrate additional capabilities for trend analysis and data-driven insights.</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Proactively maintain and interpret current international regulations, guidelines, and policies relevant to West’s products and services and provide guidance to cross-functional teams.</span></li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Education</b></H2> </div><div><ul> <li style="font-family:arial, helvetica, sans-serif;text-align:justify"><span style="font-family:arial, helvetica, sans-serif">Bachelor's or Master’s degree in science, engineering, or related discipline</span></li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Work Experience</b></H2> </div><div><ul> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Bachelors Degree with minimum 5 years experience or Master’s Degree with minimum 3 years experience </span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Experience in the area of development, scale-up and registration of regulated medical devices and combination products.</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Proficiency in using project management software and regulatory tools.</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Excellent interpersonal, communication, and organizational skills with a proven record of working with and influencing multi-disciplinary teams and external experts.</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Strong leadership skills with team management and decision-making abilities.</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Self-motivated, proactive, and able to work independently in fast-paced environments.</span></li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Preferred Knowledge, Skills and Abilities</b></H2> </div><div><ul> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Proven track record of successful regulatory submissions and interactions with regulatory authorities.</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical and medical device operations (e.g., manufacturing, process development, analytical, quality assurance). </span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Strong analytical, critical thinking and problem-solving skills.</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif;font-weight:bold"><strong><span style="font-family:arial, helvetica, sans-serif">Experience in regulated combination product, medical device development, registration of class I and class II medical devices, and profound knowledge of industry-specific regulations and standards.</span></strong></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Exceptional project management skills, including planning, execution, and budget management.</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Fundamental knowledge of Quality Management System (QMS) requirements, State-of-art standards (ISO 13485, ISO 14971, ISO 15223, IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. </span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Experience in medical device life-cycle Management, including change controls, device complaint investigations, CAPAs, and post-market surveillance.</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Regulatory Affairs Certification (R.A.C) and/or Project Management Professional (PMP) Certification</span></li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Physical and Mental Requirements</b></H2> </div><div><ul> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Ability to comprehend principles of math, science, engineering, and medical device use</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Ability to review, collate, describe, and summarize scientific and technical data</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Ability to organize complex information and combine pieces of information to form general rules or conclusions</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Ability 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 commitments</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Ability to verbally communicate ideas and issues effectively to other team members and management</span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Ability to write and record data and information as required by procedures</span></li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Travel Requirements</b></H2> </div><div><p>Must be able to travel up to 10% of the time</p></div></div></div><p><span style="color:white">#LI-DJ1 #LI-HYBRID</span></p> <p>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 <a href="mailto:[email protected]">[email protected]</a>. 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.</p>