REGULATORY IMPACT ASSESSMENT STRATEGY jobs in CAMBRIDGE, United Kingdom

. You will be responsible for the development of a CMC and device regulatory strategy, working closely with Technical Operations colleagues. The... submissions Responsible for the regulatory assessment of change controls, maintenance of regulatory files and tracking databases...

, 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...

partners to ensure optimal development execution of the agreed regulatory strategy Responsible for overseeing the preparation... improvement across regulatory affairs helping team members learn and develop aspects of regulatory strategy and research, to lead...

, Global Regulatory Affairs, Oncology Summary / purpose of the position To be accountable for the strategy, tactics... commercialization challenges into regulatory strategy (not limited to trademarks, licensing agreements, product sourcing, legal status...

support for all project related activities for multiple products. Provides medical strategy and input into key regulatory... looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create...

), company procedures and business requirements. Define in collaboration with key stakeholders of the validation strategy... following a risk-based approach as per ICH Q9 and ensuring regulatory and GMP requirements are met. Prepare validations...

and patients. You will also have the opportunity to contribute to our internal client engagement strategy under the guidance of the... understanding of medical marketing strategy, enabling you to support project teams with defining the approach to, and measuring the...

and patients. You will also have the opportunity to contribute to our internal client engagement strategy under the guidance of the... understanding of medical marketing strategy, enabling you to support project teams with defining the approach to, and measuring the...

data capture system for each study. Drive data strategy – assessment of risks and mitigations related to data management... for continuous improvement. Provide input into activities associated with regulatory inspections/audits and to the selection...

Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global.... Will drive decision making and work closely with the Clinical Project Manager to provide input to operational strategy...