Principal, Regulatory Affairs Intelligence

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

About Us

At West, we’re a dedicated team 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.

We empower the physical, mental, emotional, and financial health of our team members and their families through comprehensive benefit programs. 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.

About the Role

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.

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.
• Represent West externally on drug containment and handling topics; communicate key learnings internally to drive proactive regulatory response; and identify 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.

Requirements

• Bachelor’s, Master’s degree, or PhD in science, math, engineering, or related discipline.
• 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 Qualifications

• Global regulatory competency.
• Advanced degree.
• Experience with transfer devices and drug delivery systems.
• Experience with large molecules (e.g., biologics).
• Regulatory Affairs Certification (R.A.C.).

Skills

• Comprehend principles of math, science, engineering, and medical product use.
• Handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
• Research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
• Review, collate, describe, and summarize scientific and technical data.
• Organize complex information and combine pieces of information to form general rules or conclusions.
• Utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
• Assess, plan, schedule, and manage multiple long-term and short-term projects, tasks, responsibilities, and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to timeline commitments.
• Effective team member and work well with others in a team environment on cross-functional and/or matrix teams.
• Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures.
• Build strong relationships both internally and externally.
• Ability to work in a fast-paced environment.
• Able to work collaboratively across all levels of the organization to influence action and reach consensus.
• Experience directly interacting and presenting to project teams, customers, and industry groups.
• Strong negotiation and decision-making skills.
• Excellent written and verbal communication skills.
• Proven leadership capabilities with a strong track record in time management, project coordination, and driving cross-functional initiatives to successful completion.
• 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.
• Proficiency in the use of personal computers and computer programs, particularly Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents).

Schedule

Sedentary work involving sitting most of the time. May stand or sit for extended periods.

Travel Requirements

10%: Up to 26 business days per year.

Physical Requirements

Sedentary—Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body.