Principal Regulatory Affairs Project Manager, Medical Devices

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Requisition

Location:

Exton, PA, US, 19341

Department:
Regulatory Affairs

Description:

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.

• 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.

• 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…