Lead Regulatory Manager, International
Exact Sciences
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇵🇱 Poland
Visit company websiteJob Level
Senior
About the role
- Support or lead the creation and submission of product Technical Files/Standard Technical Documentation and other submission related documents for market authorizations in targeted markets and countries
- Support or lead regulatory strategy development for assigned projects
- Assist in creating, developing, and implementing global regulatory affairs procedures
- Participate, lead or support the preparation and maintenance of regulatory submissions
- Control and maintain regulatory records
- Manage distributors and RA consultants to ensure global registrations are completed on time
- Review and approve documents and product changes for regulatory compliance
- Review technical publications, articles, and abstracts to stay abreast of regulatory and technical developments
- Provide Regulatory reviews and approvals of advertising, promotional and external product training materials
- Demonstrate continuous pursuit of global regulatory knowledge
Requirements
- Bachelor’s degree in Physical or Life Sciences; or a High School Diploma/ General Education Degree (GED) and at least 5 years of relevant career experience in lieu of Bachelor’s degree
- 7+ years relevant experience in a regulated pharmaceutical or medical device environment
- Basic computer skills to include Internet navigation, Email usage, and word processing
- Proficient in Microsoft Office
- Authorization to work in the European Union
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Benefits
- robust benefits to support your life while you’re working to help others
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategy developmentregulatory submissionsregulatory compliancetechnical documentationregulatory records managementglobal regulatory knowledgeproduct changes reviewadvertising reviewpromotional material reviewexternal product training materials review
Soft skills
leadershipcommunicationorganizational skillsattention to detailcollaboration