Role OverviewThe Sr. Specialist, Regulatory Affairs is responsible for publishing, formatting, and maintaining 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.
What You Will Do
Publish, format, and maintain regulatory submissions, compile and prepare electronic submission packages, perform compliance reviews, and maintain organized and secure shared regulatory platforms.
Why It Might Be a Fit
This role requires a strong understanding of documentation control and compliance processes, attention to detail, and ability to manage multiple concurrent assignments and deadlines independently.
Requirements
- Bachelor's degree in a scientific or technical discipline OR equivalent experience
- Minimum 5 years of regulatory pharmaceutical or medical device experience OR Master's degree in relevant discipline with minimum 1 year regulatory experience
- 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
Benefits
- Benefit programs
- Lifelong learning, growth and development opportunities
- Inclusive community of professionals
- Sustainability efforts
- Safety policy
- Quality policy
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