Title:  Specialist, Regulatory Affairs

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:

In this dual role, you will be responsible for the coordination/authoring of customer Letter of Authorization/Access (LOA) requests for the National Medical Products Administration (NMPA) and for Chinese (Mandarin) translations of regulatory submissions and supporting documentation for West’s products and processes. Maintain knowledge of current Asia Pacific and international regulations/guidelines/policies applicable to West’s products and services.

Essential Duties and Responsibilities:

• Complete customer regulatory requests for LOAs including authoring, reviewing and approval of LOAs and provide documentation to customers and NMPA
• Manage LOA system, including maintenance and tracking of Asia Pacific LOAs for submission to NMPA, with support
• Complete structured regulatory assignments with support for R&D and commercial programs with a focus on translating, maintenance and tracking of CMC dossiers for submission to Health Authorities
• Translate/review/edit assigned technical project documentation, certifications, correspondences, and external communications, as needed
• Manage and coordinate with outside translation services, as needed
• Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to team and RA management
• 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
• Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance
• 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
• Bilingual; Fluent in English and Chinese/Mandarin (written and communication)

Preferred Knowledge, Skills, and Abilities:

• Experience with Health Authorities and/or in regulatory CMC with technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance)
• Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required
• Excellent interpersonal, communication and listening skills with a proven record of working with and influencing multi-disciplinary teams and external experts
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times

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: ability to work in an office; may need to stand or sit for extended periods of time
• 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.