CMC Regulatory Affairs Manager
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Belgium
Visit company websiteExplore more
About the role
- Develop, plan and execute appropriate regulatory strategies of pre-clinical, clinical (early to late stage), and commercial stage programs
- Responsible for preparing and managing CMC regulatory submissions
- Coordinate, write and review responses to regional and global Health Authorities
- Participate to the authoring and preparing BLA, J-MAA, MAA and ROW applications (module 2 and 3) and related life cycle documents
- Providing strategic input into CMC risks assessment and mitigation plans
- Conduct regulatory assessments for CMC change controls and oversee submission of amendments for clinical phases.
Requirements
- University degree in life sciences or related health sciences (BS/BA/MS or equivalent, PhD)
- 8+ years regulatory experience in the pharmaceutical/health care industry
- 5+ years Regulatory CMC experience
- Strong technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, Switzerland, Australia, China, and Rest of World)
- Strong regulatory CMC authoring skills
- Excellent English language (written and oral) communication skills as well as local language where applicable
- Must be familiar and able to work with RIMS (e.g Veeva RIMS), eDMS (e.g. Veeva, Documentum) and Change Management (e.g. Trackwise) systems.
Benefits
- Health insurance
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategiesCMC regulatory submissionsBLA authoringJ-MAA authoringMAA authoringROW applicationsregulatory assessmentsrisk assessmentmitigation plansregulatory CMC expertise
Soft skills
communication skillsstrategic inputcoordinationwriting skillsreviewing skills
Certifications
university degree in life sciencesBSBAMSPhD