Principal, Regulatory Affairs Intelligence

Principal, Regulatory Affairs Intelligence

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. 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. 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 – Intelligence, Pharmaceutical is a highly experienced and strategic professional who operates with minimal supervision. This role requires deep expertise in global regulatory frameworks, with a specialized focus on containment systems (i.e., primary packaging), pharmaceutical manufacturing and handling, and regulatory requirements applicable to drugs and drug constituents of combination products. The successful candidate will translate regulatory intelligence into informed business decisions, build internal capability, and strengthen West's external technical presence through thought leadership and policy advocacy.

Essential Duties and Responsibilities Perform surveillance activities by researching, identifying, analyzing, and communicating evolving global regulatory requirements that impact development, registration, submission, post-marketing, and lifecycle management of West's products and services. Surveillance areas include, but are not limited to, primary packaging; pharmaceutical manufacturing, handling, and quality management systems; enforcement trends; and other requirements for pharmaceutical and combination products (e.g., compendia). Synthesize regulatory intelligence and emerging trends into actionable insights for internal stakeholders and external customers through Master Regulatory Plans, trainings, presentations, white papers, technical publications, and other communication tools as appropriate.

Ensure timely communication of regulatory changes that impact product development, compliance, and lifecycle management. Collaborate with R&D, Quality Assurance, Clinical, Product Management and other functions to provide regulatory guidance throughout the product lifecycle and ensure alignment with applicable regulatory requirements. Provide internal training and build organizational capability on regulatory requirements and updates related to containment systems, pharmaceutical manufacturing and handling, and applicable pharmacopeial standards.

Monitor and evaluate regulatory initiatives; partner with subject matter experts to develop aligned public comments and position statements on proposed regulations and guidance; and support external engagement on policy and standards matters relevant to West's products, services, and One West objectives. Maintain a high level of regulatory awareness and strong business acumen by engaging with external experts, vendors, trade associations, coalitions, standards-setting bodies, and industry working groups to support global regulatory strategies;

representing West externally on drug containment and handling topics; communicating key learnings internally to drive proactive regulatory response; and identifying opportunities for West to contribute to broader policy and standards discussions in alignment with One West objectives. Manage relationships with regulatory vendors, ensuring timely delivery of documentation and materials. Perform other duties as assigned, contributing to the broader regulatory affairs strategy and compliance efforts.

Education Bachelor's, Master's degree or PhD in science, math, engineering, or related discipline Work Experience Bachelor's degree and minimum 8 years of pharmaceutical experience or equivalent experience;
Master's degree/PhD and minimum 5 years of regulatory/pharmaceutical experience Demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality systems and assurance, handling) Preferred Knowledge,

Skills and Abilities

Global regulatory competency Advanced degree Experience with transfer devices and drug delivery systems preferred Experience with large molecules (e.g., biologics) preferred Able to comply with the company's safety and quality policies at all times License and Certifications Regulatory Affairs Certification (R.A.C.) preferred…