Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

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.

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 include driving material compliance to applicable global product and/or packaging regulatory/environmental legislations, managing and submitting regulatory reports, communicating with West's suppliers, developing compliance processes, monitoring regulations, providing regulatory guidance, and maintaining effectiveness when experiencing major changes in work responsibilities or environment.

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: Technical leadership skills, understanding of global pharmaceutical, medical device, and related environmental and material-compliance regulations, self-motivated with a proactive attitude, ability to work effectively, and maintain working knowledge of computer software packages.

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.

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 View email address on click.appcast.io. 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.