Title:  Specialist, Regulatory Affairs, Intelligence

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:

The Specialist, Regulatory Affairs, Intelligence is expected to perform with as-needed supervision and is responsible for ensuring regulatory compliance through monitoring and communicating current and upcoming changes to regulations, guidance and standards. This position includes supporting internal and external customer regulatory intelligence requests.

Essential Duties and Responsibilities:

• Lead global surveillance activities by monitoring, identifying, and communicating up-to-date global regulatory requirements to the Regulatory Intelligence team which facilitate registration, submission and post marketing of West’s products and services; surveillance areas include, but are not limited to, pharmaceutical packaging, medical devices, labeling and software
• Administer and mature regulatory intelligence platforms and report on changes to monitored territories for potential impact on West portfolio and business
• Contribute to action plans for current and future industry initiatives
• Ensure timely notification and coordinate West responses to draft guidance, standards, consultations, and other external facing documents 
• Coordinate external consultant activities including managing feedback, review and approval of SOWs and purchase orders; act as a liaison between West and the external consultant to ensure project goals are met
• Coordinate completion of any internal or customer inquiries related to changing regulations and guidance 
• 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: Bachelor’s with 3-5 years; or Master's degree/PhD with 1+ years

Preferred Knowledge, Skills and Abilities:

• Regulatory compliance competency including Quality Systems
• International regulatory competency
• Regulatory Affairs Certification (R.A.C)
• Experience with administration and drug delivery systems preferred
• Able to work collaboratively across all levels of the organization to influence and persuade others.
• Experience directly interacting and presenting to cross-functional project teams, customers, industry groups
• Excellent written and verbal communication, timeline management and leadership skills
• 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

Travel Requirements:

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

Physical & Mental Requirements:

• Sedentary environment; ability to work in an office; may need to stand or sit for extended periods of time
• Ability to comprehend principles of math, science, engineering, and medical device use
• Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality
• 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
• Ability to review, collate, describe, and summarize scientific and technical data
• Ability to organize complex information and combine pieces of information to form general rules or conclusions
• Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one
• Ability to 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
• Ability to be an 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
• Ability to build strong relationships both internally and externally
• Ability to work in a fast-paced environment
• Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above
• Ability to verbally communicate ideas and issues effectively to other team members and management
• Ability to write and record data and information as required by procedures
• 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.