Director, Regulatory Affairs, Intelligence

 

This role is hybrid (3 days onsite) in Exton, PA. Candidates applying must be currently residing within a 50-mile commutable radius to the location or willing to relocate to the job location.

 

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 Director, Regulatory Affairs, Intelligence is expected to perform with minimal supervision and is responsible for strategic implementation of a regulatory intelligence network that encompasses separate regulatory functions, cross-functional team members and external partners to provide daily monitoring of the regulatory landscape as it relates to West products. Intelligence gathered will then be deployed to the organization through effective notifications, master regulatory plans, coordinated trainings.   
• The Director will be responsible for managing regulatory personnel, overseeing the development of a knowledge management system, and identifying key regulatory intelligence tools to further the team’s capabilities.
• The Director will drive action to ensure updated information is incorporated into revised policies and/or procedures.

 

Essential Duties and Responsibilities:

• Develop strategic processes for regulatory surveillance activities including active daily monitoring, comment solicitation, and managing critical suppliers of regulatory intelligence inputs.  Lead a regulatory team that monitor, analyze, and outline action plans for current and future industry initiatives and draft public comments in response to regulations and guidance issued by regulators and health authorities.
• Proactively research and articulate the latest regulatory intelligence to internal cross-functional stakeholders (including, but not limited to, Regulatory Affairs, Clinical, Quality Assurance, Research & Development, and Customers). Contextualize the scope and applicability to West’s portfolio and ensure that changes to applicable regulations are clearly and effectively communicated to drive effective impact assessments and action.
• Convert identified applicable regulatory intelligence into documented master regulatory plans, robust policy documentation, procedures, white papers and training, as applicable, to ensure compliance.
• Oversee information sharing in the form of periodic meetings with Regulatory Management and key stakeholders to provide trends, actions, and owners on major regulatory updates.
• Provide proactive support to customers and external stakeholders on emerging regulatory trends through blogs, webinars, publications and/or industry presentations.
• Identify and qualify vendors, tools, and systems to build efficiency in regulatory intelligence and knowledge management activities.
• Build influence through engagement in relevant trade associations, coalitions, and alliances.
• Foster career growth opportunities through training, mentorship and guidance of direct reports, RA staff and peers to define and achieve personal, departmental, and corporate objectives.
• Adhere to all applicable government and West regulations, best practices, and procedures to maintain compliance.  Work with authors to