Senior Regulatory Affairs Specialist

Description

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week.

No relocation is provided for this opportunity

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.

In this role, you would be responsible for coordinating, authoring, and managing material compliance for West’s products, including parenteral packaging, device, and contract manufacturing portfolios. With minimal support, this role ensures timely and high‑quality execution of all regulatory deliverables and ensures compliance with West and government requirements with focus on environmental regulations. This role supports material change controls, internal and external customer regulatory requests, R&D product development, and maintaining knowledge of current US and international regulations/guidelines/policies applicable to West’s products and services.

In addition, this role mentors team members and provides training to internal team members.

• Drive material compliance to applicable global product and/or packaging regulatory/environmental legislations (e.g. PPWR, EUDR, PFAS) for West’s product portfolios
• Manage and submit regulatory reports in accordance with applicable regulations and reporting deadlines
• Communicate with West’s suppliers requesting documentation and/or questionnaires to support compliance with applicable regulations and customer inquiries
• With minimal support, develop compliance process including establishment of user requirements for tools supporting compliance process where applicable
• Manage change controls and/or changes to supplier material compliance information and determine impact for West
• Monitor regulations, legislations and policies and provide regulatory guidance and communicate regulatory progress, decisions, strategies to cross functional teams
• Provide customers with West product compliance information and data as required for regulatory compliance and submissions to North America, Europe, and Rest of World agencies
• Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures
• Challenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive change
• Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to team and RA management
• Other duties as assigned

• Bachelor's, Master's degree or PhD in science, math, engineering or equivalent experience

• Minimum 5 years of experience in Regulatory, Product Stewardship, Environmental Regulations or equivalent

• Possesses technical leadership skills, as well as demonstrated understanding of global pharmaceutical, medical device, and related environmental and material‑compliance regulations
• Self‑motivated with a proactive attitude and the ability to work effectively
• Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures
• Maintain…