- Insmed Incorporated (San Diego, CA)
- …for each other, and for the future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader on ... (fast track, RMAT, etc.)Proactively communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from the VP of … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Medical Affairs , Medical Analytics will be responsible ... dashboards to communicate key findings and recommendations to internal stakeholders, including senior leadership and medical affairs teams. Ensure utilization of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director...quality and compliance.Evaluate risks impacting GxP compliance within Medical Affairs , driving ongoing improvements to meet regulatory … more
- Merck & Co. (Rahway, NJ)
- …innovation and leveraging it for how we operationalize CMC. This individual will be a senior member of the Regulatory Affairs CMC organization and will also ... manage significant cross-modality projects as an extension of the overall Regulatory Affairs CMC Leadership Team.-This Lead plays a critical role in driving… more
- Merck & Co. (Rahway, NJ)
- …execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre-clinical and ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has...closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage… more
- Merck & Co. (Upper Gwynedd, PA)
- …analysis, regulatory reporting, and publication. -- Responsibilities: Specifically, the Senior Director may be responsible for: -Analyzing and summarizing ... radically changes the way we approach serious diseases. --The Senior Director will report to an Associate...closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage… more
- Eisai, Inc (Nutley, NJ)
- …of MSLs in the region and works collaboratively with the Medical Affairs Senior management with strategic and tactical planning, working collaboratively ... profile, we want to hear from you. The Associate Director / Director , MSLs is responsible for the leadership,...with Medical Affairs and Clinical Development teams for support of clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx ... trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and...strategy to account for external shifts. Partners with Medical Affairs and Commercial to support scientific collaborations with KEEs,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the potential to dramatically influence stakeholder perceptions. Relationships Reports to the Senior Director , Media & Stakeholder Relations, and interacts with ... as we work together to change lives for the better. The Position The Director , Media Relations & Issues Management is accountable for establishing and leading Novo… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The National Senior Director , US Field Medical is responsible for the direct leadership of ... responsibilities, and initiatives for respective therapeutic area. The National Director will provide significant input into designing, developing, and implementing… more
- Merck & Co. (Millsboro, DE)
- …SOPs, Quality Notifications and technical documentation; collaborate cross-functionally with QA, Regulatory Affairs , EHS, Engineering, BTS, ATS and HR.Direct ... Job DescriptionJoin our Millsboro Senior Leadership team and lead a high-impact Integrated Process Team that directly influences site performance, product quality… more
- Merck & Co. (North Wales, PA)
- …execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating pre-clinical and ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has...closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage… more
- Stryker (San Jose, CA)
- The ** Senior Director , Regulatory Affairs ** is a key strategist, responsible for developing regulatory strategy for the **Endoscopy business unit** ... partnership with business unit leadership, Marketing, R&D, Clinical and Quality teams, the Senior Director and team will develop and advise on product… more
- Penn Medicine (Philadelphia, PA)
- …Street, Philadelphia, PA + Hours: 8hr Days **Summary** : The Senior Corporate Director of Regulatory Affairs for Penn Medicine provides leadership and ... Management and Leadership: Manage and provide leadership to all entity directors of regulatory affairs , ensuring alignment with Penn Medicine goals and … more
- Lilly (Indianapolis, IN)
- …medicines to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will ... for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and...leverage CMC technical knowledge and regulatory science expertise to drive regulatory CMC… more
- BeOne Medicines (San Mateo, CA)
- …or health-related discipline, with at least 12+ years of experience in regulatory affairs , in advertising/promotion, labeling or related discipline + and ... medical affairs , and marketing. + Provide advice on healthcare regulatory matters across business functions, including commercial, clinical development, medical … more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …learn, grow and become your best self. Become a **maker of possible** with us. The Sr. Director , Regulatory Affairs is the ranking Regulatory Affairs ... RA business partners, provides input into the budget process for Regulatory Affairs + Represents the Platform in interactions/negotiations with global … more
- Ascendis Pharma (Princeton, NJ)
- …As part of the Regulatory Affairs team, you will report to the Senior Director Regulatory Affairs , Advertising and Promotion. This position will ... as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and...help evaluate and mitigate potential risk. + Present to senior management and cross-functional teams regarding shared learnings from… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs , Neuroscience is responsible for developing ... and representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead discussions of regulatory strategy… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …in cell therapy. The Associate Director will report to a Senior Director in Regulatory Affairs , Advertising and Promotion. **This position will be ... continue making a positive impact in the cancer field. The Associate Director , Regulatory Affairs , Advertising and Promotion is responsible for providing… more
