Sr. Specialist, Regulatory Project Mgmt

 

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:

This Senior Specialist, Regulatory Project Management (RPM) role is responsible for management of regulatory affairs projects associated with West’s global portfolio of medical devices, combination products, SaMDs, and packaging components. The RPM will work collaboratively with cross functional teams and lead the regulatory team through all project phases to support submissions including Premarket Notifications, Technical Documentations under EU MDR (Medical Device Regulation), and Master Files (DMF/MAF) associated with pharmaceutical partner’s NDAs (New Drug Applications), ANDAs (abbreviated new drug applications), BLAs (Biologics License Applications). They should maintain knowledge of current international regulations/guidelines/policies applicable to West’s products and services. This position includes providing regulatory guidance and updates to internal and external stakeholders in line with defined regulatory plans. 

Essential Duties and Responsibilities:

• Act as the RPM lead on cross-functional regulatory projects across the entire lifecycle (Pre-Sub, Sub, Post-Sub, and Post-Approval) and ensure timely execution of project objectives in line with regulatory affairs (RA) team’s priorities.  
• Manage the preparation, review, and submission of complex global regulatory filings, information request responses, change notifications, and post-market surveillance reports/compliance reports.  
• Independently analyze and track regulatory project progress against pre-defined milestones, develop integrated timelines, and be proactive in identifying and escalating project risks/technical gaps to leadership teams. 
• Participate in regulatory planning and support the development of global regulatory strategies, with consideration of latest guidance documents and current state-of-art standards/regulations. 
• Collaborate with regulatory lead(s), cross-functional project manager(s) and SMEs (Subject Matter Experts) in R&D, quality assurance, clinical affairs, labeling, to align on deliverables for global submissions, establish key regulatory positions, and to ensure product development and lifecycle management activities are performed in compliance with applicable regulatory requirements.  

• Present and implement action plan(s) for regulatory risk remediation and submission issue resolution. Maintain issue logs/register(s) and manage risk mitigation efforts for the entire lifecycle of the project.  
• Generate and maintain regulatory project charter(s) and/or project dashboard(s) that deliver informative performance metrics and other critical information to stakeholders.  
• Prepare for and manage regulatory audits and inspections by authorities, ensuring all findings or nonconformities are timely addressed and submitted to authorities.  
• Remain current on evolving regulations, guidelines, and industry trends to inform regulatory actions.