REGULATORY CLINICAL STRATEGY SUBMISSIONS jobs in UNITED KINGDOM, United Kingdom #2

for regulatory submissions regarding: Clinical trial applications; New marketing applications; HA responses & background packages... with project teams; in particular with regards to technical issues that may impact regulatory submissions, strategy, or success...

of regulatory affairs from clinical trials to lifecycle management in medicines and medical devices. Responsibilities: - Oversee..., and other products. - Ensure all submissions to regulatory authorities are of high quality and conducted in a professional and timely...

Regulatory Department, providing exposure to various aspects of regulatory affairs from clinical trials to lifecycle management... information and documentation for medicines, medical devices, and other products. - Ensure all submissions to regulatory...

for submission in the relevant countries Manages strategy and execution for all regulatory CMC submissions (e.g. late stage clinical... regulatory strategies and providing feedback to internal teams regarding submission plans and execution of the strategy...

for submission in the relevant countries. Manage strategy and execution for all regulatory CMC submissions (e.g. late stage clinical... regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified...

for submission in the relevant countries. Manage strategy and execution for all regulatory CMC submissions (e.g. late stage clinical... regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified...

embedded role ICON’s Regulatory Strategy group, you will lead or contribute to the development and execution of the drug... and making regulatory submissions via CTIS. You will be supporting the EU regulatory team with planning and executing regulatory...

related to clinical trial submissions managed by other stakeholders such as IB, Protocols. Ensuring the approved company...Job Title: Regulatory Affairs Coordinator CTA, CTR (Consultant) Job Type: 12 Month Contract Location: Berkshire, UK...

and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within the client's portfolio... and/or support staff. Responsible for: Advising the Global Regulatory Team on regional considerations in developing strategy...

and manage regulatory submissions (e.g. clinical trial and marketing applications) in compliance with global filing plans... interactions consistent with the Global Regulatory strategy- including contingency regulatory planning/risk assessment. Plan...

and manage regulatory submissions (e.g. clinical trial and marketing applications) in compliance with global filing plans... interactions consistent with the Global Regulatory strategy- including contingency regulatory planning/risk assessment. Plan...

Job Purpose As a Senior Manager, Regulatory Affairs CMC, you are an integral part of MoonLake’s Clinical Development.... You will be responsible for the development of a CMC and device regulatory strategy, working closely with Technical Operations colleagues. The...

European regulatory affairs experience (must have) Experience in Clinical Trial Applications in the EU (must have) Innovative... for a Senior Manager - Regulatory Affairs to work within the Global Regulatory Affairs - Innovative Medicines (Europe) team...

on pre-clinical and clinical development plans and work with both Regulatory Affairs New Products and Regulatory Affairs... most efficient way. This will encompass Regulatory strategy planning, supporting due diligence assessment for any innovative assets...

as local HA liaison (e.g., FDA or EMA). Regulatory Submissions Leads planning, preparation and submission of clinical... regulatory strategy for program(s) through development, registration and post approval in the assigned region(s). They may act...

line with legal/regulatory requirements and regional business needs. Supports clinical trials strategy... on , , , and . Job Description Job Summary Is responsible for implementation of registration strategy to ensure the regulatory approval of commercially...

is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions... to current regulatory requirements and expectation for biologics/cell therapy marketing applications, clinical trial applications...