Regulatory CMC Manager, Regulatory Consulting
Lifelancer
full-time
Posted on:
Location Type: Hybrid
Location: London • United Kingdom
Visit company websiteExplore more
About the role
- Support the execution of multi-product global regulatory CMC for products at Marketing Authorisation Application Stage
- Contribute to the preparation and submission of regulatory CMC documentation
- Provide regulatory support to various cross-functional teams
- Contribute to strategic Regulatory CMC discussions
Requirements
- Experienced CMC Regulatory Manager
- Authoring of CMC sections for Marketing Authorisations dossiers
- Reviewing CMC sections of regulatory submissions
- Working with regulatory colleagues in development of global regulatory CMC strategies and submissions
- Participating on cross-functional teams and serving as the primary regulatory CMC contact for assigned products and projects
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
CMC authoringregulatory submissionsregulatory documentationglobal regulatory strategies
Soft skills
cross-functional collaborationstrategic discussionscommunication
Certifications
CMC Regulatory Manager