- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ Lead a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory strategy and plans for assigned global projects. + Gain endorsement from ... product's lifecycle and across different indications. + Represent Global Regulatory Affairs on the GPT (Global Project... risks, and opportunities in the development of global regulatory strategy and plans, considering therapeutic area… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and plan ... in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred **Travel** Ability… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for ... Years in the pharmaceutical industry required. + 8 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the drug… more
- Novo Nordisk (Princeton, NJ)
- …a difference? The Position Reporting to the Senior/Executive Director or Vice President of Regulatory Affairs , the Director of Regulatory Affairs ... compliance-related activities. May supervise others. Relationships Reports to the Senior/Executive Director or Vice President, Regulatory Affairs . Essential… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #386 Tuesday, August 20, 2024 Looking for a chance to make a ... expanding mid-size oncology company in the role of Associate Director , Regulatory Affairs Operations where...years of pharmaceutical industry experience in developing and implementing regulatory submissions strategy for early and late… more
- Bausch Health (Bridgewater, NJ)
- …**KEY ACTIVITIES/** **RESPONSIBILITIES:** + Serve as a leadership team member for Global Regulatory Affairs + Lead and grow individuals on the Regulatory ... standards and other best practices guidelines + Identify opportunities to streamline Regulatory Affairs processes to promote operational excellence + Provide… more
- Ascendis Pharma (Princeton, NJ)
- …We offer a dynamic workplace for employees to grow and develop their skills. The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for ... labeling, and for coordinating internal labelling activities and processes for regulatory submissions and product maintenance. The Associate Director prioritizes… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi ... strategy . + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and...relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA… more
- Bristol Myers Squibb (Princeton, NJ)
- …careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with...with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience… more
- Bristol Myers Squibb (Princeton, NJ)
- …7-10+ years Pharmaceutical industry experience, including multi-disciplined experience, 6+ years CMC regulatory strategy . + Knowledge of CMC regulatory ... database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for content development,… more
- Integra LifeSciences (Princeton, NJ)
- …with colleagues in the Marketing, Business Development, R&D/Process Technologies Clinical Operations, Strategy , Regulatory Affairs , Market Access, and other ... Global Tissue Technologies and International teams to shape Integra Medical Affairs strategy and priorities. **SUPERVISION RECEIVED** Under direct supervision… more
- Abbott (Princeton, NJ)
- …Affairs (GMSA), Abbott Point of Care + Contribution to global Medical & Scientific Affairs strategy in conjunction with Directors of EMEA and APAC Medical ... operational performance. Our location in Princeton, NJ currently has an opportunity for a Director of Medical Affairs , Americas. The Director of Medical … more
- Bausch + Lomb (Trenton, NJ)
- …leading the advancement of eye health in the future. **Position** **Summary** The Medical Affairs Director provides support to the Medical Affairs /Clinical ... Medical Director reports directly to the Executive Director , Medical & Scientific Affairs . **Major Areas.... **Contacts (Internal And** **External)** + **Internal:** US Medical Affairs , Regulatory Affairs , Clinical Operations,… more
- Sumitomo Pharma (Trenton, NJ)
- …be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy . In this role, individuals are responsible for ... Commercial launch strategy and guide the tactical implementation of Medical Affairs plans. The Associate Director will also collaborate with company outreach… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …level, while also seeking their input and feedback to inform state government affairs strategy and engagement. Contributes to internal and external advocacy and ... and immune disorders. **Summary** With the Head of Government Affairs & Public Policy, this position will help lead...Policy, develop, lead and prioritize Daiichi Sankyo's legislative and regulatory engagement and strategy in the states… more
- Novo Nordisk (Princeton, NJ)
- …personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain ... positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...documents for inclusion in these applications + Review of regulatory strategy documents; eg, provides supervisor with… more
- US Tech Solutions (Titusville, NJ)
- …including: + Partnership across Medical Affairs , RW V&E, JRD, Brand Marketing, Regulatory Affairs , Global Medical Affairs , New Business Development, J&J ... Corporate Communications, and J&J Legal, field based Medical Affairs personnel + Education strategy and oversight...Doctorate, PhD, or PharmD + Will be monitoring trials, regulatory affairs , etc with competition + Will… more
- Ascendis Pharma (Princeton, NJ)
- …the US Medical Directors to drive the development and execution of the US Medical Affairs strategy and tactics in alignment with key stakeholders. . Develops and ... assets at Ascendis Pharma. In addition to leading the strategy and execution of phase IV (post-marketing, Registry, Early...Ascendis Pharma. . Works closely with Compliance, Legal and Regulatory to ensure that all US Medical Affairs… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global ... goals and regulatory submissions in accordance with regulatory strategy for moderately complex programs and...through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more