Amandine Rousseau is a eficient expert, who works in Sanofi Genzyme main office of which is in 518. as a Senior Manager Global Regulatory Affairs - Cmc Biologics from 2018. This person gained professional experience in more than nine positions at different companies. Amandine Rousseau went to the Paris - Sud University (Paris Xi) and got education there from 2003 to 2004. This person has such qualifications as Translation and Writing of Biomedical and Pharmacological English Diploma and Universite Lumiere Lyon 2. Westboro, Massachusetts is the area, where this professional was lastly known to live. This expert's e-mail and phone can be accessed through SoftwareOfficial by request.
Name variants:
Amandine Rousseau
Last updated Jun 29, 2024
Contact Information
Last Update
Jul 13, 2022
Email
ac**@hotmail.fr, am**@genzyme.com, am**@sanofi.com
Location
Westboro, MA
Company
Sanofi Genzyme
Workplace
Senior Manager Global Regulatory Affairs - Cmc Biologics
Work History
Senior Manager Global Regulatory Affairs - Cmc Biologics
50 Binney St, Cambridge, MA 02142
Oversight for monoclonal/polyclonal antibodies and enzyme replacement therapy products (five biological products total). Global Regulatory CMC Product Lead for an early stage monoclonal anti...
from Mar 2018
Associate Principal Regulatory Affairs - Cmc Biologics
50 Binney St, Cambridge, MA 02142
Product Lead for monoclonal antibodies (post-market and development products): Responsible for Global regulatory strategy and submissions. Acting as US affiliate, routinely interacts with th...
Aug 2015 — Mar 2018
Regulatory Affairs Cmc Project Manager
50 Binney St, Cambridge, MA 02142
Managed CMC dossier readiness for a Tech Transfer in a new biopharmaceutical facility (> 60 countries including the US, EU, Japan, Canada): Project Management, defined regulatory strategy, d...
Apr 2008 — Aug 2015
Cmc Associate Manager
CMC representative for a range of pharmaceutical products. Assessed regulatory impacts of industrial change requests
defined CMC strategy
prepared submission packages to support worldwide...
Dec 2005 — Mar 2008
Change Control Project Leader
Assessed regulatory/quality/business impacts of change requests issued by manufacturing sites
prepared variation packages for submission (EU & International)
answered to Authorities quest...
2004 — 2005
Regulatory Affairs Specialist
Prepared first registrations/renewals/tenders for a product range for International countries (outside US/EU); provided regulatory support to affiliates.
Mar 2004 — Sep 2004
Qa and Compliancetrainee
Prepared DMFs for the US annual reports; wrote DMFs in the CTD format.
May 2003 — Aug 2003
Pharmacist Student
Developed a Quality Assurance system for sterilisation of medical devices in a new central sterilisation unit. Wrote Quality Manual and SOPs.
Oct 2002 — Mar 2003
Qa Trainee
Performed method validation, performed an internal audit, wrote standard operating procedures and non conformity reports, checked batch records before product release.
Jun 2001 — Sep 2001
Education
2003 — 2004
1998 — 2003
Occupations
Executive
Senior Manager
Scientist
Biotechnology Professional
Operations Manager
Biologist
Biological Scientist
Skills
Regulatory Affairs
Biotechnology
Change Control
Regulatory Submissions
Gmp
Pharmaceutical Industry
Pharmaceutics
Fda
Regulatory Requirements
Biopharmaceuticals
Validation
Ectd
Cmc
Sop
U.s. Food and Drug Administration
Compliance
Pharmaceuticals
V&V
Verification and Validation
Standard Operating Procedure
FAQs about Amandine Rousseau
What is the main profession of Amandine Rousseau?
Amandine Rousseau is a Senior Manager Global Regulatory.
What are the main profession of The expert?
These person's professions are Executive and Senior Manager
Where is Amandine Rousseau currently located?
Amandine Rousseau is located in Westboro, Massachusetts.
Does Amandine have the email address?
ac**@hotmail.fr and am**@genzyme.com is The professional's email address.
How many companies did Amandine Rousseau work at?
Amandine Rousseau worked at nine jobs.
Where has Amandine Rousseau studied?
Amandine studied at the Paris - Sud University (Paris Xi) from 2003 to 2004.
What are the certifications of Amandine Rousseau?
The professional received the following certifications: Translation and Writing of Biomedical and Pharmacological English Diploma and Universite Lumiere Lyon 2.
What languages does Amandine Rousseau speak?
Amandine Rousseau speaks French, English, Spanish, and Russian.