Associate Director Regulatory Affairs Strategy Jobs

... the development of the CMC regulatory strategy for submissions. These submissions include ... IND/CTA, NDA, CTD and MAA regulatory filings. Collaborate with other relevant ... health authorities. Responsible for..

... long-term strategic approach for Global Regulatory Compliance Identify and monitor key ... and ensuring compliance with current regulatory policy, legislation and guidance Identify ... if appropriate, anticipate changes to..

... on internal/external system audits and regulatory agency inspections Responsible for business ... with IT to execute the strategy Reviews and approves GxP impact ... research, analytical, quality, engineering, manufacturing,..

... Responsibilities Leadership responsibility for global regulatory strategy within the Hematology portfolio. Responsible ... portfolio. Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing ... for..

... Development, Manufacturing Sciences and Technologies, Regulatory Affairs, and other Cell Therapy Development ... Therapy Development Organizations to ensure regulatory compliance of GMP operations in ... WA and reports to..

... and make a difference. POSITION Associate Director/Director, WW Medical Affairs Hematology Myeloid SUPERVISOR Senior Director, WW Medical Affairs Hematology Myeloid DEPARTMENT WW Medical ... Hematology Myeloid DEPARTMENT WW Medical..

... transformative business results. Summary/Scope: The Associate Director will report to the US ... report to the US Medical Affairs (USMA) Director, Myeloid Data Strategy Lead. He/she will be head..

... stakeholders and sharing information and strategy with the countries. Responsibilities will ... ensure market understanding of; medical strategy, integrated brand data generation plans, ... regional/WW interface Develop with Medical..

... Advise and support local Global Regulatory Sciences (GRS) for assessing regulatory landscape and regulations to optimize ... and regulations to optimize our regulatory strategies and submission plans within .....

... and make a difference. POSITION Director, Regulatory Affairs SUPERVISOR Senior or Executive Director, Regulatory Affairs DEPARTMENT Global Regulatory Affairs PREREQUISITES Bachelors in scientific discipline; ... industry experience in in..

... transformative business results. Summary The Associate Director will assume leadership responsibility for ... assume leadership responsibility for global regulatory strategy within a development team (DT). ... indications that are..

... Product Quality Lead (Principal PQL), Associate Director of Global Product Quality. The ... Development, Manufacturing Sciences and Technologies, Regulatory Affairs, and other Cell Therapy Development ... Therapy Development Organizations..

... on internal/external system audits and regulatory agency inspections Responsible for business ... with IT to exexute the strategy Reviews and approves GxP impact ... documentation system in compliance with..

... a difference. The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply ... apply complex scientific and expert regulatory advice and risk assessment for..

Job Information Bristol Myers Squibb Associate Director GxP External Engagement in New ... the External Engagement team, the Associate Director, GxP External Engagement plays a ... of the GxP external..

... make a difference. Position: Executive Director, Regulatory Affairs Team Leader Supervisor: Vice President, ... Team Leader Supervisor: Vice President, Regulatory Affairs Department: Global Regulatory Affairs Prerequisites Bachelors in scientific..

... Therapeutic Area Head Support the Regulatory Affairs Therapeutic Area Head for IN&F ... leading and developing the global regulatory strategies, overseeing health authority interactions ... hiring, retention, and development..

... transformative business results. Summary: The Associate Director, Global Risk Management Strategy reports to the Executive Director, Global Risk Management Strategy and will be responsible for ... Plans and/or REMS..