Senior Regulatory Affairs Specialist

Job 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.

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

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.

Essential Duties and Responsibilities

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

Work Experience Minimum

• 5 years of experience in Regulatory, Product Stewardship, Environmental Regulations or equivalent Preferred Knowledge, Skills and Abilities 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 working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this

Job Description

Able to comply with the company’s safety and quality policies at all times Travel Requirements 5%: Up to 13 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

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

• Ability to 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
• Maintain the ability to work well with others in a variety of situations 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 [email protected]. 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.