Declan Kelly Email and Phone Number
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Experienced Vice President, Regulatory Affairs CMC with a demonstrated history of leadership in the pharmaceuticals industry. Strong regulatory professional, skilled in large and small molecule Regulatory Requirements, U.S. Food and Drug Administration (FDA) and Global HA requirements, Technology Transfer, and Validation.
Sanofi
View- Website:
- sanofi.com
- Employees:
- 88327
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Global Head Regulatory Affairs Cmc And DevicesSanofiNew York, Ny, Us
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Global Head Regulatory Affairs Cmc & DevicesSanofi Nov 2020 - PresentParis, France, Fr
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Vice President,Regulatory Affairs CmcAllergan Plc Nov 2011 - Jul 2020Head of Regulatory CMC Department responsible for delivering global CMC dossier and regulatory strategies to support development and commercial products. Lead internal and external partners to deliver CMC content for IMPD, INDs, NDA and Global MAs. Train, develop and drive team performance to deliver CMC submissions to support Corporate Goals. Leader of FDA and other Global Health Authority negotiations/meetings. Product Development Team leader (PDTL) for Memantine /Donepezil HCL Combination Product. Joint Development Committee (JDC) Member for Aclidinium Inhalation and Memantine/Donepezil HCL Capsules partner projects
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Executive Director Regulatory CmcBristol-Myers Squibb Sep 2005 - Dec 2011Lawrence Township, Nj, UsLead CMC department of 25 people, responsible for global CMC regulatory strategies for large and small molecule products; e.g. new Biologic API and finished product facility start-up/transfers, small molecule API and finished product transfers and line extension submissions. Manage International Product Registration/TSE department of 4 people (e.g., CPP, TSE/BSE statements, sample requirements, etc.) to support international regulatory requirements for development and established products.Leader of FDA and other Global Health Authority negotiations/meetings.Responsible for US, EU, LA and AP regulatory CMC strategy for all post approval changes including routine change control for biological and small molecule products.Lead regulatory strategy for Plant Consolidation Project (4 site consolidation, approximately 1500 submissions globally for 2008 and 2009).Support new product regulatory CMC strategies in global markets. -
Director Regulatory CmcSchering-Plough Research Institute Jun 2002 - Sep 2005Kenilworth, New Jersey, UsCompany representative for all CMC changes required for Consent Decree activities (4 sites, 23 products and 9 API’s).Regulatory Chair on the Consent Decree, Validation Certification Program Steering Committee. Responsible for review of NDA CMC section and site documents to ensure conformance to FDA regulations, prior commitments and regulatory trends.Identify content, responsibilities and timing of CMC documents through our Change Management program for all post-approval CMC changes. Determine the submission strategy and content based on current Regulatory Guidelines and experience.Manage 4 direct reports and 2 consultants. -
Manager, Production ServicesSchering-Plough Animal Health Corporation Dec 1997 - Dec 2002Project leader responsible for coordination between, and providing technical assistance to, Formulations, Clinical Research, Manufacturing, Quality Control, Packaging and Regulatory Affairs for new and existing products for domestic and international markets.Development of manufacturing, validation, Q.C. and stability protocols to facilitate technology transfer of products from Research and existing manufacturing sites to new commercial manufacturing sites.Perform cost analysis between sites to determine the most cost-effective site for manufacturing.Provide to Regulatory Affairs documentation needed for CMC section of NADA submission.
Declan Kelly Skills
Declan Kelly Education Details
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Dublin City UniversityAnalytical Chemistry
Frequently Asked Questions about Declan Kelly
What company does Declan Kelly work for?
Declan Kelly works for Sanofi
What is Declan Kelly's role at the current company?
Declan Kelly's current role is Global Head Regulatory Affairs CMC and Devices.
What is Declan Kelly's email address?
Declan Kelly's email address is de****@****frx.com
What schools did Declan Kelly attend?
Declan Kelly attended Dublin City University.
What skills is Declan Kelly known for?
Declan Kelly has skills like Fda, Regulatory Affairs, Validation, Technology Transfer, Pharmaceutical Industry, Change Control, Regulatory Requirements, Regulatory Submissions, Gmp, Cmc, Quality Control, 21 Cfr Part 11.
Who are Declan Kelly's colleagues?
Declan Kelly's colleagues are María Elizabeth Tapia López, Chloé Raynal, Stefania Codega, Sarah Courtman, Nadia Jourde, Samantha Canfin, Dianne Jennings.
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