Regulatory Affairs CMC Manager, Mature Products
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Siena • 🇮🇹 Italy
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Responsible for the global CMC regulatory activities for assigned projects
- Develops CMC strategy and submission documents to support marketed product lifecycle management activities
- Advises teams on regulations, guidelines, procedures and policies relating to medicinal products
- Ensures all appropriate CMC regulatory aspects for product release are in place
- Works in cross-functional matrix project teams to define proper regulatory CMC filing strategy
- Maintains high quality standards and seeks continuous improvement
- Engages in CMC Subject Matter Expert activities internally
- Delivers CMC regulatory strategy to support major inspections with managerial support
Requirements
- Bachelor or Master Degree in life sciences or related scientific discipline
- Regulatory Affairs Certification (RAPS)
- Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience with direct involvement in regulatory submission preparation in late phase development and/or marketed product life cycle submissions
- Sound knowledge of drug development, manufacturing processes and supply chain
- Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for marketed products
- Fluent English both written and spoken.
Benefits
- Healthcare and wellbeing programmes
- Pension plan membership
- Annual bonus based on company performance
- Shares and savings programme
- Flexible benefits
- Employee Assistance Programme
- Prevention services and vaccination clinic
- Local nursery agreement
- Postal service, laundry, shoe repair and tailoring
- On Site Gym
- On Site canteens and coffee corners
- Free company bikes and shuttle
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
CMC regulatory activitiesregulatory submission preparationdrug developmentmanufacturing processessupply chain managementregulatory CMC filing strategyquality standardscontinuous improvementdossier compliancemarketed product lifecycle management
Soft skills
cross-functional collaborationadvisory skillscommunicationmanagerial supportsubject matter expertise
Certifications
Regulatory Affairs Certification