Principal, Regulatory Affairs Intelligence

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.

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 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

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. Sedentary work involves sitting most of the time.

Additional Requirements

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 time-line 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 if changed by the Company).

Position operates in a professional office environment. May stand or sit for extended periods of time.

Able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures

Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities

Able to multi-task, work under time constraints, problem solve, and prioritize

Ability to make independent and sound judgments

Observe and interpret situations, analyze and solve problems

What We Offer

Community Involvement: West encourages volunteerism through its West without Borders initiative and other charitable programs that make a difference in local communities.

Continuous Learning & Development: Opportunities for professional growth through training programs, tuition assistance, leadership development, and skill-certification initiatives.

Generous Paid Time Off (PTO): Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work-life balance and recharge effectively.

Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where all voices are heard and respected in a supportive environment.

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

#LI-DJ1 #LI-HYBRID

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.