REGULATORY STRATEGY AND SUBMISSIONS jobs in CAMBRIDGESHIRE, United Kingdom

. You will be responsible for the development of a CMC and device regulatory strategy, working closely with Technical Operations colleagues. The...: Responsible for the development and execution of global regulatory CMC and device strategies and submissions, including CMC...

of the regulatory submissions meets ICH and regional/local regulatory requirements. Perform CMC regulatory submissions... identification of CMC risk areas and development of alternative courses of actions. Contribute to regulatory strategy and filings...

and national regulatory strategies based on registration requirements, product knowledge and company strategy. Maintain oversight... and provide regulatory insight to optimise the regulatory strategy in relation to the product lifecycle. Partner with the...

the regulatory strategy, plans and objectives for assigned products or projects. You will lead Regulatory Submissions... Regulatory Lead across multiple approved marketed established products or other programs. You may lead Regulatory Submissions...

will include defining the regulatory strategy, plans, and objectives for assigned products or projects. Additionally..., you will oversee the preparation and maintenance of CMC regulatory submissions for assigned products or projects, guiding and advising...

. Finally, this role works with cross-functional areas to determine the appropriate strategy for labels for regulatory authority... and efficient promotional review process. Partner with Global Regulatory Strategy and Labeling on future/planned labeling updates...

and strong collaboration with Commercial Marketing, Medical Affairs, PRC/MRC Coordinators, Legal Affairs, Regulatory Affairs Strategy, Labeling.../APLB, including response to regulatory inquiries, preparation of complete, accurate, high-quality submissions for advisory...

with Commercial Marketing, Medical Affairs, PRC/MRC Coordinators, Legal Affairs, Regulatory Affairs Strategy, Labeling Operations...Title: Associate Director, US Regulatory, Advertising & Promotion Company: Ipsen Biopharmaceuticals Inc...

with Amgen’s corporate standards. Your responsibilities will include planning and managing EMA regulatory submissions... execute the filing plan for the EMA Ensure regulatory submissions are made on time and meet Amgen’s corporate and local...

successful reimbursement of these therapies. To date, the HTA team at Costello Medical have worked on over 200 submissions to national... to develop the HTA strategy for their product that then informs the delivery of multiple project types including the medical...

. Expertise in preparing clinical safety assessments and regulatory reports/submissions involving safety information. Experience... potential safety signals. Contribute to the strategy and review of safety assessments and for signals or issues (including...

Specialist plays a significant role in shaping and delivering the Commercial functional strategy by ensuring that sales targets.../private sector contracts, wholesaler invoices and dispensing doctor scheme, and manage internal pricing control submissions...

through co-authorship. The candidate may also provide support in regulatory submissions including responses to regulatory... Programming, Data Management, Regulatory Strategy and Operations, Medical, Outcomes Research, Commercial, Operations and contract...

improvement support, and compliance monitoring to support a wide variety of regulatory submissions across all therapeutic... or related strategy to successful conclusion for multiple products. Experience working as a Global or Regional Regulatory Lead...

-related CMC sections of IND/IMPD and BLA/MAA regulatory submissions. Knowledgeable in European, Japanese, Chinese and US CMC... regulatory requirements for Biologics Develop, implement and execute a smart sourcing strategy Deep and broad knowledge...

to ensure appropriate case processing. Contribute to regulatory authority submissions (Investigational New Drug/IND... and regulatory reports/submissions involving safety information. Experience working with vendor teams and providing oversight...

, and monitors the Data Management strategy for one or more clinical studies in Ipsen portfolio. The Study Lead is responsible... analysis and reporting process in such a way the evaluation of data will withstand interrogation and examination by regulatory...