Regulatory Team In The UK Continues To Grow.......
Posted: Tue Nov 15, 2022 12:05 pm
Joyce Reader - Senior Regulatory Consultant, Geron Corporation (contract)
Hired - Nov 2022
10/20/2022 - FOSTER CITY, Calif.- (BUSINESS WIRE)- Geron Corporation (Nasdaq: GERN) reported that it has granted non-statutory stock options to purchase an aggregate of 843,260 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company. Joyce Reader is one of these newly hired employees.
Joyce Reader's former employers include: Jazz Pharmaceuticals (UK), GW Pharmaceuticals (UK), Gilead (UK), Biogen (UK), Pfizer (UK), Abbott Laboratories (UK), GlaxoSmithKline (UK), Sanofi-Aventis (UK), UCB (UK), Reader Regulatory LTD (UK), Regulatory Live (UK).......
*Detect a pattern here (UK) ?????
Joyce Reader is a "CMC Regulatory Expert" (her words):
"Joyce Reader has over 30 years’ CMC regulatory affairs experience in several leading global pharmaceutical companies working on a wide range of dosage forms for clinical trial, MAA/NDA and post approval aspects for regulatory submissions. expert knowledge of the requirements of all global regions."
1 - "Regulatory Manager (CMC Biologics)
UCB
Jan 2018 - Jun 2019 1 yr 6 mos
Slough, United Kingdom
Strategic support for Phase 3 Clinical Trial CMC submission preparation (EU, Canada, US and ROW countries), including Response to Questions and Phase 3 post approval changes. CMC documentation preparation for MAA/BLA submissions and response to questions."
2 - "Interim Manager, Regulatory Affairs, CMC
Gilead Sciences
Aug 2015 - Sep 2017 2 yrs 2 mos
Cambridge, United Kingdom
Provision of regulatory submission support for registrations to the Commercial & Access Emerging Markets Team.
Provision of continued interim management support for new registrations and support on-going post-approval maintenance activities in Emerging Markets.
Support preparation of new ROW modules for new products as required and to support new CTA filings in ROW markets."
3 - "Regulatory Affairs Manager - Emerging Markets
Biogen Idec
May 2014 - Aug 2015 1 yr 4 mos
Maidenhead (UK) Office
Interim Associate Director - A member of the Global Emerging Markets Leadership Team specifically managing MENA markets including South Africa.
Product Lead for Interferon franchise of products; providing strategy and management for new regulatory submissions and life cycle management.
Team management in support of Biogen portfolio of products in the region, including CMC, artwork/labelling and safety/indication updates.
Cross functional management; working with local distributor, commercial, artwork division, to align business decision and strategy for the region.
Member of MERN working in partnership EFPIA and Regulatory in the Middle East to develop legislation and regulatory best practices."
4 - "AfME Conformance Lead
Pfizer
Apr 2011 - Apr 2014 3 yrs 1 mo
Maidenhead and Walton Oaks (UK) Offices
• Responsible for managing a team of regulatory professionals (5 UK and 4 Dubai
based) in support of lifecycle submissions for all Pfizer products specifically for
Africa and Middle East (AfME) markets and EU emerging markets (+ 85 countries)
• Lead the provision of submission strategy and project management for all CMC
changes originating at plant or Pfizer country offices (PCOs - affiliates) to maximize
efficiencies, quality and rate of submission approvals at BoH
• Provide regional/local management of lifecycle submissions in markets under
responsibility, including: Market Application amendments, variations, renewals,
response to HA questions
• Ensure CMC change and documentation management electronic database systems are
updated and maintained to align with the regulatory information submitted/approved
externally by a Board of Health or internally by the appropriate functional area
• Maintain regulatory requirements intelligence for AfME region relating to all post
approval changes/renewals
• Creation of training material and delivery for new systems management, roles and
responsibilities to direct reports and PCO (country affiliates)."
**Detect a pattern here.....UK, US, EU, Canada, Middle East, Africa, South Africa, (+85 countries) ???
***WOW !!!! All I can say is, Dr. Scarlett and Sharon McBain ain't messing around.
****Expect a PR concerning UK Regulatory submission at any time now. -Kmall
Hired - Nov 2022
10/20/2022 - FOSTER CITY, Calif.- (BUSINESS WIRE)- Geron Corporation (Nasdaq: GERN) reported that it has granted non-statutory stock options to purchase an aggregate of 843,260 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company. Joyce Reader is one of these newly hired employees.
Joyce Reader's former employers include: Jazz Pharmaceuticals (UK), GW Pharmaceuticals (UK), Gilead (UK), Biogen (UK), Pfizer (UK), Abbott Laboratories (UK), GlaxoSmithKline (UK), Sanofi-Aventis (UK), UCB (UK), Reader Regulatory LTD (UK), Regulatory Live (UK).......
*Detect a pattern here (UK) ?????
Joyce Reader is a "CMC Regulatory Expert" (her words):
"Joyce Reader has over 30 years’ CMC regulatory affairs experience in several leading global pharmaceutical companies working on a wide range of dosage forms for clinical trial, MAA/NDA and post approval aspects for regulatory submissions. expert knowledge of the requirements of all global regions."
1 - "Regulatory Manager (CMC Biologics)
UCB
Jan 2018 - Jun 2019 1 yr 6 mos
Slough, United Kingdom
Strategic support for Phase 3 Clinical Trial CMC submission preparation (EU, Canada, US and ROW countries), including Response to Questions and Phase 3 post approval changes. CMC documentation preparation for MAA/BLA submissions and response to questions."
2 - "Interim Manager, Regulatory Affairs, CMC
Gilead Sciences
Aug 2015 - Sep 2017 2 yrs 2 mos
Cambridge, United Kingdom
Provision of regulatory submission support for registrations to the Commercial & Access Emerging Markets Team.
Provision of continued interim management support for new registrations and support on-going post-approval maintenance activities in Emerging Markets.
Support preparation of new ROW modules for new products as required and to support new CTA filings in ROW markets."
3 - "Regulatory Affairs Manager - Emerging Markets
Biogen Idec
May 2014 - Aug 2015 1 yr 4 mos
Maidenhead (UK) Office
Interim Associate Director - A member of the Global Emerging Markets Leadership Team specifically managing MENA markets including South Africa.
Product Lead for Interferon franchise of products; providing strategy and management for new regulatory submissions and life cycle management.
Team management in support of Biogen portfolio of products in the region, including CMC, artwork/labelling and safety/indication updates.
Cross functional management; working with local distributor, commercial, artwork division, to align business decision and strategy for the region.
Member of MERN working in partnership EFPIA and Regulatory in the Middle East to develop legislation and regulatory best practices."
4 - "AfME Conformance Lead
Pfizer
Apr 2011 - Apr 2014 3 yrs 1 mo
Maidenhead and Walton Oaks (UK) Offices
• Responsible for managing a team of regulatory professionals (5 UK and 4 Dubai
based) in support of lifecycle submissions for all Pfizer products specifically for
Africa and Middle East (AfME) markets and EU emerging markets (+ 85 countries)
• Lead the provision of submission strategy and project management for all CMC
changes originating at plant or Pfizer country offices (PCOs - affiliates) to maximize
efficiencies, quality and rate of submission approvals at BoH
• Provide regional/local management of lifecycle submissions in markets under
responsibility, including: Market Application amendments, variations, renewals,
response to HA questions
• Ensure CMC change and documentation management electronic database systems are
updated and maintained to align with the regulatory information submitted/approved
externally by a Board of Health or internally by the appropriate functional area
• Maintain regulatory requirements intelligence for AfME region relating to all post
approval changes/renewals
• Creation of training material and delivery for new systems management, roles and
responsibilities to direct reports and PCO (country affiliates)."
**Detect a pattern here.....UK, US, EU, Canada, Middle East, Africa, South Africa, (+85 countries) ???
***WOW !!!! All I can say is, Dr. Scarlett and Sharon McBain ain't messing around.
****Expect a PR concerning UK Regulatory submission at any time now. -Kmall