Emmanuelle Roux

Emmanuelle Roux Email and Phone Number

Project Leader, Regulatory Affairs at Duchesnay @ Duchesnay
blainville, quebec, canada
Emmanuelle Roux's Location
Montreal, Quebec, Canada, Canada
Emmanuelle Roux's Contact Details

Emmanuelle Roux personal email

n/a
About Emmanuelle Roux

Pharmaceutical development professional with expertise in regulatory affairs and drug product development.

Emmanuelle Roux's Current Company Details
Duchesnay

Duchesnay

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Project Leader, Regulatory Affairs at Duchesnay
blainville, quebec, canada
Website:
duchesnay.com
Employees:
87
Emmanuelle Roux Work Experience Details
  • Duchesnay
    Project Leader, Regulatory Affairs
    Duchesnay Apr 2022 - Present
    Blainville, Quebec, Canada
    - Regulatory Lead for multiple products- Provide CMC regulatory expertise and ensure the compliance of the team’s work in relation to the resulting tasks.- Ensure liaison with HC for general regulatory matters and product specific issues- Research, interpret and apply regulations, directives and international politics- Liaise with internal departments and external partners/consultants to prepare andconsolidate relevant pharmaceutical and technical documents for product… Show more - Regulatory Lead for multiple products- Provide CMC regulatory expertise and ensure the compliance of the team’s work in relation to the resulting tasks.- Ensure liaison with HC for general regulatory matters and product specific issues- Research, interpret and apply regulations, directives and international politics- Liaise with internal departments and external partners/consultants to prepare andconsolidate relevant pharmaceutical and technical documents for product dossiers- Prepare and publish new drug submissions and amendments for regulatory agencies (HC,FDA, MHRA) Show less
    View
  • Duchesnay
    Senior Regulatory Affairs Associate
    Duchesnay Jul 2015 - May 2022
    Blainville, Qc, Canada
    - Regulatory Lead for multiple products- Ensure liaison with HC for general regulatory matters and product specific issues- Research, interpret and apply regulations, directives and international politics- Liaise with internal departments and external partners/consultants to prepare and consolidate relevant pharmaceutical and technical documents for product dossiers- Prepare and publish submissions (NDS) and amendments (SNDS, SNDA, PAS, CBE, AR, variation) for regulatory… Show more - Regulatory Lead for multiple products- Ensure liaison with HC for general regulatory matters and product specific issues- Research, interpret and apply regulations, directives and international politics- Liaise with internal departments and external partners/consultants to prepare and consolidate relevant pharmaceutical and technical documents for product dossiers- Prepare and publish submissions (NDS) and amendments (SNDS, SNDA, PAS, CBE, AR, variation) for regulatory agencies (HC, FDA, MHRA)- Develop CMC regulatory strategies and submissions in collaboration with Production and Quality teams to support product lifecycles- Register Duchesnay’s products on international markets Show less
    View
  • Duchesnay
    Regulatory Affairs Associate
    Duchesnay May 2014 - Jul 2015
    Blainville, Qc, Canada
    View
  • Jubilant Draximage
    Regulatory Affairs Specialist
    Jubilant Draximage Oct 2010 - May 2014
    - Prepared amendments (SNDS, NC, ADN, PAS, CBE, AR) for regulatory agencies (HC, FDA) - Researched, interpreted and applied regulations, directives and international politics- Liaised with internal departments to prepare and consolidate relevant technical documents for product dossiers - Ensured liaison with HC for general regulatory matters and product specific issues- Registered Draximage’s products on international markets
    View
  • Jubilant Draximage
    Project Manager (Short Term Contract)
    Jubilant Draximage Aug 2010 - Oct 2010
    Jubilant Draximage
    - Established development plans for pipeline products in collaboration with internal teams (R&D, validation, QO, regulatory affairs)
    View
  • Thallion Pharmaceuticals Inc (Tln)
    Project Manager, Cmc/Drug Development
    Thallion Pharmaceuticals Inc (Tln) Jan 2008 - Mar 2010
    - Coordinated/oversaw activities related to Phase 2 manufacturing and regulatory submissions: production, method validations, stability studies, specifications establishment- Prepared/submitted CTA and IND CMC sections for an oncological product - Established production forecasts and established/managed budget ($1M/year)
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  • Ecopia Biosciences
    Scientist, Formulation, Preclinical Development
    Ecopia Biosciences Oct 2004 - Dec 2007
    - Developed formulations for new drugs in preclinical and clinical studies- Developed the GMP compliant environment for the production of Ecopia’s lead API and formulation (sterile product for iv administration)- Participated in the preparation of CTA CMC sections for Ecopia’s lead product
  • Pharmascience
    Scientist, Formulation, Pharmaceutical R&D
    Pharmascience Aug 2003 - Oct 2004
    - Developed formulations and processes for immediate/modified release dosage forms and produced the stability batches for analytical evaluation- Studied relevant formulation/process patents on dosage forms of interest and designed novel approaches to develop a generic version
    View

Emmanuelle Roux Skills

Regulatory Affairs Pharmaceutical Industry Gmp Regulatory Submissions Fda Regulatory Requirements Biotechnology Clinical Development Validation R&d Glp Drug Discovery Lifesciences Sop

Emmanuelle Roux Education Details

Frequently Asked Questions about Emmanuelle Roux

What company does Emmanuelle Roux work for?

Emmanuelle Roux works for Duchesnay

What is Emmanuelle Roux's role at the current company?

Emmanuelle Roux's current role is Project Leader, Regulatory Affairs at Duchesnay.

What is Emmanuelle Roux's email address?

Emmanuelle Roux's email address is er****@****ahoo.ca

What schools did Emmanuelle Roux attend?

Emmanuelle Roux attended Université De Montréal, Université De Montréal, Université De Montréal.

What skills is Emmanuelle Roux known for?

Emmanuelle Roux has skills like Regulatory Affairs, Pharmaceutical Industry, Gmp, Regulatory Submissions, Fda, Regulatory Requirements, Biotechnology, Clinical Development, Validation, R&d, Glp, Drug Discovery.

Who are Emmanuelle Roux's colleagues?

Emmanuelle Roux's colleagues are Tina Fasone, Claude-André Boivin, Jonathan Dagenais, Vijaykrishna Vijay, Alex Aguilar, Edith Sirard, Frederick Blain.

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