Title:  Regulatory Affairs Administrator

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary:

With a focus on North America, this role is responsible for coordination/authoring of customer Letter of Authorization/Access (LOA) requests for North America to support West’s elastomeric and medical device product portfolios and regulatory submissions for West’s products and processes.  Address customer regulatory requests and maintain knowledge of current North American and international regulations/guidelines/policies applicable to West’s products and services. 

Essential Duties and Responsibilities:

• Complete customer regulatory requests for LOAs including reviewing and approval of LOAs and provide documentation to customers and FDA/Health Canada
• Manage, maintain and update LOA system with applicable reference information, customer Reponses, and any training information, for North American LOAs for submission to FDA/Health Canada, with support
• Provide assistance with customer regulatory requests, including regulatory letters and compliance questionnaires
• Complete structured regulatory assignments with support for R&D and commercial programs

with a focus on authoring, maintenance and tracking of North American LOAs for submission to health authorities.

• Manage department credit card charges, including payments to health authorities and complete expense reports on time
• 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 and seek better alternatives and drive change.
• Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance.
• Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to team and RA management

• Other duties as assigned

Basic Qualifications: 

• Education: Bachelor's, Master's degree or PhD in science, math, engineering or related discipline or equivalent experience
• Experience: 3-5 years; or master’s degree/PhD with 1+years
• Excellent interpersonal, communication and technical writing skills

Preferred Knowledge, Skills and Abilities:

• Hands-on experience in the process of generating, reviewing, and formatting documentation for worldwide regulatory submissions
• Demonstrated ability to manage multiple tasks/projects/priorities simultaneously
• Attention to detail with planning, time management and organizational skills
• Self-motivated with a proactive attitude and the ability to work effectively
• Ability to be an effectives team member and work well with others in a team environment on cross-functional teams

Travel Requirements:

• Must be able to travel up to 5-10% of the time (meetings, trainings, projects, industry events), including international travel

Physical and Mental Requirements:

• Sedentary environment: exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.
• Must be able to communicate effectively, speak in front of groups, express & exchange ideas and understand direction. 
• 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.
• Able to learn and apply new information or new skills.
• 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)

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 and/or a pre-employment drug screening.