REGULATORY CLINICAL STRATEGY SUBMISSIONS jobs in United Kingdom #2

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...

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) 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...

Quality and Regulatory Team and provide guidance to project teams on regulatory strategy and planning, quality system... design regulatory processes to join our team and work with project groups to translate novel technologies to the clinic...

experience Experience in preparing regulatory submissions Experience in working with early-stage companies, where requirements...We are seeking experts in medical device design regulatory processes to join our team and work with project groups...

experience Experience in preparing regulatory submissions Experience in working with early-stage companies, where requirements.... About us We are seeking experts in medical device design regulatory processes to join our team and work with project groups to translate novel...

, Switzerland, and the UK. In this role you will need to provide provide regulatory strategy, leadership, and operational support... strategy for development or marketed products, taking in consideration the latest precedent, regulatory intelligence, agency...

for assigned due diligences, under the direction of the Global Regulatory Strategy Lead? If so, our Biotechnology client...), paediatric plans, clinical trial designs and HA feedback. Accountable, with the GRSL, for providing a regulatory recommendation...

regulatory strategy for their assigned projects in the Vaccines and Infectious Disease therapeutic area. The selected... Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more of our Company...

, predominantly within the Medical Device and related sectors Provide leadership and expertise in regulatory and submissions-related... and submissions Supporting delivery of submission-specific regulatory milestones Ideally min degree qualified within a relevant...

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...

regulatory strategy for the UK. Ensuring full regulatory and company compliance, and provide regulatory expertise to support... to licensing, regulatory changes, and submissions to MHRA. Contributing to a Brand Team representing Regulatory Affairs...