Global Regulatory Affairs Lead Director IV, Exton, PA – Katalyst HLS

The Global Regulatory Lead is responsible for developing and directing the global regulatory strategy, objectives, policies and programs pertaining to development and marketing of drug and/or biological products. This role includes the lead regulatory responsibility for support of global registration and life cycle support and includes the leadership of regulatory strategy for multiple projects that extend globally (United States, EU, ROW, etc.) coordinating support via a Global Regulatory Strategy Team composed of core regulatory support functions.


Regulatory Submission Publisher

Job Description:
8-10 years of experience with Regulatory Submission/Publishing
systems (Lorenz preferred, Parexel Insight Publisher, CSC eCTDXpress)
5 years of experience with Regulatory Submission Validation systems
(GlobalSubmit, Lorenz, Extedo)
Experience with Validation in a Regulated Pharmaceutical environment
Knowledge on translating regulatory publishing requirements into
functional requirements.

Global Regulatory Affairs Manager, CMC – Katalyst HealthCares & Life Sciences

Global Regulatory Affairs (GRA) – Chemistry, Manufacturing and Controls (CMC). Management of change controls for the CMC regulatory affairs group for all biological, plasma and/or small molecule products. Formulating and implementing CMC regulatory strategies with the global regulatory and international regulatory leads.

Technical Writer – Regulatory, Greater Boston Area – Katalyst HLS

Perform CMC technical writing and editing assignments related to the preparation of CMC components of regulatory submissions and other technical documents including content templates, as well as any other documents determined to be within the scope of the role; and ensure that project time-lines are met

Regulatory Strategy – Associate Director job – Katalyst HealthCares & Life Sciences – Cambridge, MA |

May 24, 2018 – Regulatory Strategy – Associate Director – p b Job Description: /b /p ul li Responsible for regulatory activities supporting the development of vaccine candidates /li li Manages

Associate Director, Global Regulatory Affairs, CMC job – Katalyst HealthCares & Life Sciences – Lexington, MA |

July 18, 2018 – Associate Director, Global Regulatory Affairs, CMC I – p b Description: /b /p ul li The CMC Regulatory Affairs IgMAX Regulatory CMC strategy Team Lead will provide leadership and be the Regulatory

CMC Regulatory Affairs, Associate Director, Boston Area – Katalyst HLS

Direct and Manage Regulatory Affairs activities for developing a Core Dossier for Module 3 and preparing Module 3 documents to support Marketing Authorization Applications in Japan and Brazil. Provide support to other HA interactions as required.