Sanofi
Biopharma
GRACMCLead
“GRA CMC Lead at Sanofi. Skills: Regulatory CMC, Health Authorities, Regulatory Strategy. Manage a portfolio of projects. Manage marketed products”
Industry & Context.
Ability to solve strategic technical and regulatory problems
What They're Looking For.
Must Have
BSA degree in a relevant scientific discipline, At least 4+ years' experience in a regulatory role, Operational experience within an organization (medium to large) in Regulatory CMC department, Knowledge of global regulations/guidelines, Health Authorities, their modes of operation and their expectations, Ability to solve strategic technical and regulatory problems, Demonstrate initiative, reflection, foresight and the ability to communicate effectively with internal or external partners
Nice to Have
Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field), highly valued if it’s within the pharmaceutical industry
What You'll Do.
Manage a portfolio of projects
Manage marketed products
Define global CMC regulatory strategy
Manage variation approvals
Manage variation questions
Interact with Health Authorities
Develop CMC regulatory strategies
Assess associated risks
Participate in Change Control assessment
Guarantee collaboration within CMC teams
Implement appropriate strategies
Take risks into account
Ensure requests from Health Authorities are taken into account
Develop lasting relationships with Health Authorities
Provide support for strategic negotiations
Draft supporting documents
Prepare supporting documents
Review supporting documents
Approve supporting documents
Coordinate submission of CMC regulatory files
Monitor post-approval commitments
Manage post-approval commitments
Prepare variation files
Author Global Regulatory CMC Strategy Document
Resolve CMC regulatory issues
Support regulatory inspection process
Contribute to Sanofi initiatives
Review local regulations
Review international regulations
Ensure requirements of Health Authorities are taken into account
Communicate requirements of Health Authorities
How You'll Work.
Team & Collaboration
Work closely with Global Regulatory Affairs (GRA); Work closely with Regions ('Regional GRA'); Work closely with local regulatory teams; Work closely with quality groups within R&D; Work closely with quality groups within Industrial Affairs; Work closely with RSO (Regulatory Site Officer) teams; Work closely with partners; Work closely with Human Resources; Work closely with Legal Services; Work closely with Finance; Collaborate with all Global Regulatory Affairs entities; Guarantee collaboration within CMC teams; Collaborate with R&D functions; Collaborate with Industrial Affairs; Collaborate with Global Regulatory Affairs
Communication Scope
Ability to communicate effectively with internal or external partners
Process & Methodology
Manage a portfolio of projects
Applying for this GRA CMC Lead role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Sanofi?
Real rants from real employees. Read before you apply.