REGULATORY STRATEGY AND SUBMISSIONS jobs in HOME COUNTIES, United Kingdom #2

) and renewal documentation submitted to regulatory agencies and the patient safety contribution to global regulatory submissions... technologies. Main Duties and Responsibilities: In this role, you'll be responsible for the Clinical Safety strategy...

with technical risk assessments (FMEA) and control strategy development. Good knowledge of QbD as presented in regulatory dossiers... milestones from candidate selection through commercialisation in accordance with regulatory guidance. In partnership...

projects, compounds and/or submissions generally of low-medium complexity/criticality. The Statistical Programming Lead... strategy, specifications and plans the programming deliverables for a one or more clinical projects. May act as a section lead...

to ensure data and reporting infrastructure meets requirements for investigations, regulatory submissions, or CAPA. Basic... stakeholders in a high-profile position to drive the Ware Site’s future factory strategy and digital transformation at GSK...

for Regulatory Submissions required of changes. Participates and support in Regulatory Agency Inspections of the facilities... improvement projects. About you: Actively participate and assist in the development of the strategy and validation plan...

submissions. The candidate will be expected to design, execute and analyse experiments in the laboratory within a team setting..., supporting IND submissions and Biological Licence Applications. The Senior Scientist will be relatively independent in the...

. Contribution to the development and review of regulatory submissions and interaction with Regulatory Authorities. Oversight of the... strategy and implementation of plans to support early clinical development endpoints. Development of strong relationships...

submissions. The candidate will be expected to design, execute and analyse experiments in the laboratory within a team setting..., supporting IND submissions and Biological Licence Applications. The Senior Scientist will be relatively independent in the...

. Contribution to the development and review of regulatory submissions and interaction with Regulatory Authorities. Oversight of the... strategy and implementation of plans to support early clinical development endpoints. Development of strong relationships...

submissions are prepared and evidence collated Work with the commercial team to manage change Ensure commercial processes... are followed in all procurement activities and best value is achieved Ensure all pre-commencement and regulatory requirements...

scientists to ensure any change in risk are reported accurately in regulatory submissions. Complete audits both internally... would be most beneficial. A good understanding of the companies DOMS strategy and our participation with PODDS would also be beneficial. Make...

. Successful candidate would also participate in regulatory submissions and response to regulatory queries. The candidate will directly... contribute to Company success by increasing the strength of study designs, interpret-ability of results, regulatory strategy...

. Successful candidate would also participate in regulatory submissions and response to regulatory queries. The candidate will directly... contribute to Company success by increasing the strength of study designs, interpret-ability of results, regulatory strategy...

to desks, work benches and new equipment as required. Ensure regulatory and quality procedures relating to maintenance... want to make a difference. Direct applications only. No unsolicited Recruitment Agent submissions will be accepted. Any...