This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. No relocation or visa sponsorship is provided for this opportunity.
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 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. 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.
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.
Essential Duties and Responsibilities
With a high degree of autonomy, lead cross-functional regulatory project teams in the development and execution of global regulatory strategies across the product lifecycle, ensuring alignment with business objectives and evolving regulatory requirements.
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 risk management, and strategic decision-making.
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.
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.
Provide technical and strategic input on global regulatory plans, change assessments and agency responses.
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.
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.
Drive continuous improvement initiatives within the regulatory function, including the development and implementation of advanced project management tools, performance dashboards, and knowledge-sharing platforms.
Optimize RA databases for information requests, submissions and integrate additional capabilities for trend analysis and data-driven insights.
Proactively maintain and interpret current international regulations, guidelines, and policies relevant to West's products and services and provide guidance to cross-functional teams.
Education
Bachelors or Master's degree in science, engineering, or related discipline
Work Experience
Bachelors Degree with minimum 5 years experience or Master's Degree with minimum 3 years experience
Experience in the area of development, scale-up and registration of regulated medical devices and combination products.
Proficiency in using project management software and regulatory tools.
Excellent interpersonal, communication, and organizational skills with a proven record of working with and influencing multi-disciplinary teams and external experts.
Strong leadership skills with team management and decision-making abilities.
Self-motivated, proactive, and able to work independently in fast-paced environments.
Preferred Knowledge, Skills and Abilities
Proven track record of successful regulatory submissions and interactions with regulatory authorities.
Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical and medical device operations (e.g., manufacturing, process development, analytical, quality assurance).
Strong analytical, critical thinking and problem-solving skills.
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.
Exceptional project management skills, including planning, execution, and budget management.
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.
Experience in medical device life-cycle Management, including change controls, device complaint investigations, CAPAs, and post-market surveillance.
Regulatory Affairs Certification (R.A.C) and/or Project Management Professional (PMP) Certification
Physical and Mental Requirements
Ability to comprehend principles of math, science, engineering, and medical device use
Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality
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
Ability 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 conclusions
Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one
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
Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams
Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures
Ability to build strong relationships both internally and externally
Ability to work in a fast-paced environment
Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above
Ability to verbally communicate ideas and issues effectively to other team members and management
Ability to write and record data and information as required by procedures
Travel Requirements
Must be able to travel up to 10% of the time
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 Apply.Accommodation@westpharma.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.