Associate Director Regulatory Affairs Strategy Jobs in New Jersey

... 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..

... will have accountability as the Associate Director, WW Medical Oncology Melanoma, supporting ... Melanoma team, reporting to the Director, WW Medical Oncology Melanoma. He/she ... of the HQ Medical..

... accountability as the WW Medical Associate Director for Immuno-Oncology (I-O), supporting the ... the WW Medical Lung Cancer strategy (communication, publication, and ISR strategy). RESPONSIBILITIES Responsibilities include: supporting development..

... 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..

... 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..

... and transformative business results. POSITION Associate Director / Director of Hematology (Myeloid) Patient Advocacy ... (Myeloid) Patient Advocacy DEPARTMENT Medical Affairs - Patient Advocacy PREREQUISITES This ... with market..

Join a Legacy of Innovation 110 Years and Counting!nDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet ..

... 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..

The Regeneron Associate Director, GVP Quality Management Lead (QML) ... Regeneron global pharmacovigilance (PV) system.The Associate Director will utilize advanced interpersonal and ... in conjunction with business and Director, GVP..

... will you bring? Description The Associate Director, Competitive Intelligence (CI) & Knowledge ... and executes the vision and strategy to ensure the utilization of ... information science, literature/database and..

... 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..

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas ..

... 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..

... 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..

... 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..

... 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..

... execute on a multi-channel patient/caregiver strategy for REVLIMID and POMALYST; elevate ... partnerships with HCP marketing, medical affairs, market access, marketing operations, sales, ... operations, sales, market research, legal,..

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..

... 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 .....

... Job Title Senior Manager / Associate Director, PV & Lifecycle Management Quality ... Position Summary / Objective The Associate Director will work in the RDQ, ... and reports to..

Job Information Bristol Myers Squibb Associate Director, Safety Science in Summit New ... information May lead ad hoc regulatory safety requests by obtaining data ... input and support safety publication..