Senior Regulatory Affairs Specialist

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