Title:  Senior Manager, Regulatory Affairs

Job Summary

• The Senior Manager, Regulatory Affairs serves as a strategic leader within the Global Regulatory Affairs organization and is responsible for regulatory publishing strategy, people leadership, and hands-on oversight of complex publishing and submission activities across West’s product portfolio.
• This role partners closely with cross-functional and global regulatory teams to ensure the timely, accurate, and compliant preparation, formatting, compilation, publishing, and maintenance of regulatory documentation for submissions to health authorities in the United States, European Union, China, and Rest of World.
• The Senior Manager is expected to lead and develop team capabilities, drive process excellence, and remain closely involved in critical publishing operations to ensure high-quality execution, regulatory compliance, and successful submission outcomes.

Essential Duties and Responsibilities

• Lead the global regulatory publishing strategy and execution for West's product portfolios, ensuring regulatory submissions are prepared, formatted, compiled, published, and transmitted in compliance with applicable regulations, guidelines, and internal procedures.
• Oversee the publishing and lifecycle management of regulatory documentation, including CMC dossiers, DMFs, MAFs, 510(k)s, LOAs, and other submissions for health authorities in the U.S., EU, China, and Rest of World, while maintaining hands-on involvement in complex or high-priority publishing activities.
• Lead, develop, and manage regulatory publishing personnel by setting priorities, providing coaching and mentorship, and ensuring high-quality, timely execution of deliverables aligned with business objectives and submission timelines.
• Partner with global Regulatory Affairs colleagues and cross-functional stakeholders to ensure submission content and supporting documentation are complete, well organized, scientifically accurate, and suitable for regulatory review and acceptance.
• Oversee and continuously improve regulatory publishing processes, systems, documentation practices, and operational workflows to enhance efficiency, consistency, traceability, quality, and compliance.
• Monitor changes in the global regulatory environment, assess potential impact on publishing operations and submission standards, and provide guidance to internal stakeholders on regulatory publishing requirements and expectations.
• Communicate project status, milestones, risks, and potential issues to Regulatory Affairs leadership and key stakeholders, and support or lead health authority interactions related to regulatory publishing activities as needed.
• Perform other duties as assigned.

Education

• Bachelor’s degree in a scientific, technical, or related discipline required or equivalent experience.

Work Experience

• Minimum 10 years of regulatory affairs experience in the pharmaceutical and/or medical device industry; or a Master’s degree in a relevant discipline with minimum 5 years of regulatory affairs experience.

Preferred Knowledge, Skills and Abilities

• Demonstrated hands-on experience preparing, reviewing, formatting, and publishing documentation for global regulatory submissions.
• Working knowledge of global regulatory submission standards and requirements, including the U.S., EU, China, and Rest of World.
• Strong understanding of document control, submission lifecycle management, and compliance processes within a regulated environment.
• Strong planning, organizational, and project management skills with a high level of attention to detail.
• Ability to manage multiple priorities and concurrent deadlines in a fast-paced, deadline-driven environment.
• Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint, as well as Adobe Acrobat.
• Demonstrated ability to build effective relationships across global, cross-functional teams and work collaboratively to achieve shared objectives.
• Strong written and verbal communication skills, with the ability to clearly convey information to technical and non-technical stakeholders.
• Demonstrated commitment to accuracy, quality, regulatory compliance, and adherence to SOPs and company policies.
• Ability to adapt effectively to change, maintain performance through shifting priorities, and proactively identify opportunities for process improvement.
• Demonstrated accountability, ownership, and follow-through on deliverables and timelines.
• Ability to comply with company safety and quality policies at all times.

License and Certifications

• Pharmaceutical and Medicine\Regulatory Affairs Certifications (RAC)-RAPS Regulatory Affairs Certification (R.A.C) Upon Hire preferred

Travel Requirements

Physical Requirements

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.

What We Offer