- Bristol Myers Squibb (Indianapolis, IN)
- …team, RayzeBio aims to be the global leader in radiopharmaceuticals . Associate Director of Regulatory Project Management will plan, execute and oversee ... + Bachelor's degree or higher + A minimum of 7 years of experience in regulatory project management + Hands-on experience with NDA filing is a must + Oncology … more
- Boehringer Ingelheim (St. Joseph, MO)
- …as governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or ... to drive Target Product Profile objectives. + Provides consistent regulatory advice to project teams regarding the...as defined. + Supports specific infrastructural projects as assigned. Associate Director + Responsibility for the safety… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs, Neuroscience is responsible ... for developing innovative global regulatory strategies and providing strategic regulatory guidance...and Takeda R&D. **How you will contribute:** + The Associate Director will be responsible for increasingly… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead, GRAD Oncology. You will ... in collaboration with their regional counterparts. + As the Associate Director , you will be responsible for...are effectively implemented and maintained in line with changing regulatory and business needs. + Ensures project … more
- Takeda Pharmaceuticals (Boston, MA)
- …for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Director , Regulatory Data Governance Lead **POSITION ... DESCRIPTION** : Takeda Development Center Americas, Inc. is seeking an Associate Director , Regulatory Data Governance Lead with the following duties: Oversee… more
- Takeda Pharmaceuticals (Boston, MA)
- … strategies in collaboration with their regional counterparts. **Accountabilities:** + The Associate Director will be responsible for complex or highly complex ... needs and anticipates such changes to lead adaptations to regulatory strategy. + Ensures project team colleagues,...(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types. + Accountable for… more
- Rhythm Pharmaceuticals (Boston, MA)
- …learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be responsible ... cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs. Responsibilities and Duties...Affairs. Responsibilities and Duties + Act as the Global Regulatory Lead on multi-disciplinary project teams and… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... medicine promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs...and commercial materials. + You will be product or project business lead for global CMRP at Takeda +… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work ... Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC...annual licenses, registrations, listings and patent information. + Create project plans and timelines. + Lead cross functional groups… more
- AbbVie (Mettawa, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Regulatory Affairs US Advertising and ... cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global… more
- J&J Family of Companies (Spring House, PA)
- …and if approved by the Company. **We are searching for the best talent for Associate Director , Regulatory Medical Writing - Oncology.** **Purpose:** + Able ... compound independently. + Leads in setting functional tactics/strategy. + Leads project -level strategy (eg, submission team, global program team, clinical team). +… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …site and Friday remotely on a weekly basis. **Summary of Job Responsibilities** The Associate Director of Regulatory Affairs will provide regulatory ... is not limited to the development and implementation of regulatory strategies for new product submissions, project ...of regulatory strategies for new product submissions, project management for regulatory affairs submissions, handling… more
- GRAIL (Washington, DC)
- …technology, and healthcare companies. For more information, please visit grail.com . The Associate Director of Global Regulatory Affairs & Safety serves ... GRAIL's UK Responsible Person (UKRP). Interfaces with MHRA and other International regulatory agencies, Notified Bodies, and external consultants as needed, on IVD… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the development and submission of ... SME members that may include, Development Manufacturing Supply and Quality (DMSQ), Regulatory Project Management & Program management, and external cross… more
- Kemin Industries (Des Moines, IA)
- Overview Kemin Health is hiring an Associate Director of Regulatory /Scientific Affairs and Quality! In this role, you will be responsible for leading the ... business units' regulatory affairs (RA) and quality assurance (QA) teams by...Project Verification. + Stay abreast of the changing regulatory , legal, quality and competitive landscape. + Assess and… more
- Merck (De Soto, KS)
- **Job Description** Join our Global Engineering Solutions leadership team as the Associate Director , Project Technical Lead! The Associate Director ... selection, design, startup and commissioning and qualification through all phases of the project . The Associate Director participates in project … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... and serves as ad hoc member to the Global Project Team for late stage projects. This position manages...& variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disclosure for collection, retention, testing and retesting of samples + Project Team Participation: Provide device-specific regulatory insight/guidance during ... around rare diseases and immune disorders. **Summary:** Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Gilead Sciences, Inc. (Foster City, CA)
- …or other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional ... together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds,...direct reports. + Provides matrix management and leadership to project teams. + Provides accurate and thorough input and… more
- United Therapeutics (Madison, WI)
- …like lungs, pancreases and hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory pathways, managing documentation and ... timelines, and supporting the preparation and execution of regulatory submissions for our whole organ tissue engineering program....a related area of study + 8+ years of project or people management experience + Must have written… more