This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. Job SummaryThe Sr. Specialist, Regulatory Affairs is responsible for the publishing, formatting, and maintenance of regulatory documentation supporting West's global product portfolios. This role ensures regulatory submissions are prepared accurately and in compliance with applicable global health authority requirements. This position operates independently on assigned regulatory projects, collaborates cross-functionally, and escalates regulatory risks appropriately to Regulatory Affairs leadership. The role focuses on high-quality execution, compliance, and continuous improvement within established regulatory frameworks.
Essential Duties and Responsibilities- Publish, format, and maintain regulatory submissions (DMFs, Dossiers, MAFs, 510(k)s, and related filings) in alignment with global regulatory requirements
- Compile and prepare electronic submission packages according to regional health authority guidelines and internal standards
- Retrieve, organize, and provide regulatory documentation in response to customer and agency requests
- Perform compliance reviews of assigned technical documentation, certifications, and correspondence to ensure completeness, accuracy, and adherence to regulatory requirements
- Maintain organized and secure shared regulatory platforms to support collaboration with customers, consultants, and regulatory bodies
- Partner with R&D, Quality, Operations, and Commercial teams to gather required submission documentation and ensure alignment to project timelines
- Communicate project status, milestones, and potential issues clearly to stakeholders; escalate regulatory risks and concerns appropriately to RA management
- Adapt effectively to evolving regulatory requirements and changing project priorities
- Identify and support implementation of process improvements within assigned regulatory operations to enhance efficiency and documentation quality
- Support Lean Sigma initiatives and continuous improvement efforts within the Regulatory Affairs function
- Perform other duties as assigned
Education- Bachelor's degree in a scientific or technical discipline OR equivalent experience
Work Experience- Minimum 5 years of regulatory pharmaceutical or medical device experience OR
- Master's degree in relevant discipline with minimum 1 year regulatory experience
Preferred Knowledge, Skills and Abilities- Hands-on experience preparing, reviewing, and formatting documentation for global regulatory submissions
- Working knowledge of global regulatory submission standards (U.S., EU, China, ROW)
- Strong understanding of documentation control and compliance processes
- High attention to detail with strong planning and organizational skills
- Ability to manage multiple concurrent assignments and deadlines independently
- Proficiency in Microsoft Office (Excel, Word, PowerPoint) and Adobe Acrobat
- Builds effective working relationships across global, cross-functional teams
- Shares information clearly and supports team objectives
- Maintains high standards of accuracy and regulatory rigor
- Adheres consistently to SOPs, regulatory requirements, and company quality policies
- Adjusts effectively to changing priorities and regulatory updates
- Maintains performance during periods of change
- Proactively identifies opportunities to improve assigned processes
- Supports implementation of approved improvements within the function
- Takes ownership of assigned deliverables and timelines
- Demonstrates reliability and follow-through in a deadline-driven environment
- 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 Requirements5%: Up to 13 business days per year
Physical RequirementsSedentary-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- 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)
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