- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and ... regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global … more
- Takeda Pharmaceuticals (Columbus, OH)
- …members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project Management and Strategic Planning (RPM&SP) head. Identify and propose ... - Neuroscience where you will partner with the Global Regulatory Lead (GRL) on Global Regulatory... regulatory . + Advanced education or credentialing in regulatory affairs and project management… more
- Abbott (Alameda, CA)
- …This is an exciting opportunity at Lingo. **What You'll Work On** + Represent Regulatory Affairs on cross functional project teams and provide strategic ... Abbott is a global healthcare leader that helps people live more fully at...future of healthcare. As an individual contributor, the **Senior Regulatory Affairs Specialist** will support product development… more
- Actalent (Boston, MA)
- …submission + Track status and progress of regulatory documentation + Understand Regulatory Affairs ' position in small project team Top Skills Details: ... Regulatory Affairs Associate- MEDICAL DEVICE Description:...for submission in support of global products. + Supports regulatory project plan execution + Maintain awareness… more
- ThermoFisher Scientific (Waltham, MA)
- …dedicated and meticulous ** Project Administrator** to join our Corporate Quality & Regulatory Affairs project management team. The Project ... We are a fast-paced and innovative company, and our global Quality & Regulatory teams mirror this dynamic. Focused on collaboration and partnership, we work together… more
- Abbott (Plano, TX)
- …Texas locations, currently have an on-site opportunity for a ** Regulatory Affairs Manager** . This position leads project submissions for regulatory ... Abbott is a global healthcare leader that helps people live more fully at...manages complex projects and prioritizes workload. + May manage regulatory budget at team or project level.… more
- Abbott (Austin, TX)
- …or Austin, Texas locations, currently have an opportunity for a ** Regulatory Affairs Manager** . This position leads project submissions for regulatory ... Abbott is a global healthcare leader that helps people live more fully at...resolve problems. This new team member will apply advanced regulatory expertise to guide cross-functional partners and demonstrate strategic… more
- Bristol Myers Squibb (Trenton, NJ)
- …Access + Clinical Research & Development + Biostatistics + Translational Development + Regulatory Affairs + Project Leadership + External: + Investigators, ... BoW. He/she will be reporting to the WW Medical Oncology Thoracic/ H&N Cancers Lead and participate in the cross functional matrix teams to provide scientific and… more
- Actalent (Laguna Hills, CA)
- …Adagio compliance. Post-market and vigilance reporting process. Represent Regulatory Affairs on Engineering & R&D product development project teams to ... Description: This position is a regulatory affairs specialist for a medical...while preparing responses to deficiency letters and/or questions from regulatory agencies. MDR transition project to maintain… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …research aspects of registration activities with a working knowledge of regulatory affairs , in the development of the project strategy and the clinical ... Affairs , Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs , Pharmacovigilance) Strategy/Portfolio Management, Global Device… more
- Lilly (Indianapolis, IN)
- …from CMOs, Manufacturing & Quality (M&Q) central functions, Product Development (PR&D) and Regulatory Affairs . The Associate Director, Project Manager - DPEM ... with the GPLOT leader and ensure/facilitate technical project governance in collaboration with the Tech Lead...Networks (such as M&Q central functions, Product Development and Regulatory Affairs ). + DPEM and Lilly External… more
- BeiGene (Emeryville, CA)
- …This position will have oversight for supporting functional areas such as Regulatory Affairs (CMC, Strategy, Project Management), Quality/Manufacturing, ... of Submission Dossier Managers with strong collaboration with the Regulatory Project Management function. + Provide direction...lead on global programs within R&D and Global Regulatory Affairs , including the ability to … more
- Caris Life Sciences (Phoenix, AZ)
- …collaboration with the Software Development, Bioinformatics, IT, Information Security (InfoSec), Regulatory Affairs , project /program management, and other ... of an Off-the-shelf (OTS) computerized system. Partner with a lead auditor to ensure the supplier's software development and...+ Plan and coordinate own work according to higher-level project schedule demands. + Assist in internal, external, and… more
- TestPros (Silver Spring, MD)
- …policies, standards, and procedures. + Collaborate with cross-functional teams, including IT, Regulatory Affairs , and Project Management, to ensure security ... to making lives better, safer and more secure. Job Title: Cybersecurity Lead Citizenship: US Citizenship Location: Hybrid ( Rockville, MD and/or Silver Spring,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …requirements for reporting and analytics** + Engage with key stakeholders, including Regulatory Affairs teams and cross-functional project team members, ... Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible...regions and sub-functions + Partner with the Process Excellence Lead and others to identify process improvements based on… more
- Gilead Sciences, Inc. (Los Angeles, CA)
- …Arcus Biosciences) + Partners closely with corresponding Franchise Heads in Clinical Development, Regulatory , Med Affairs , Project Mgmt, and other key ... direct impact. We believe every employee deserves a great leader . People Leaders are the cornerstone to the employee... in a disease area. **Key Responsibilities:** + Will lead a large team (approx. 30-50 people) and serve… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Global Regulatory Affairs Lead ** + Location: Cambridge, MA or Bridgewater, NJ **About the job** The Global Regulatory Affairs Lead ... global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS), Global Submission Strategy, and core product… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of professionals, who work with Gilead's global portfolio of small molecule products in CMC Regulatory Affairs . This position will lead a global group that ... with headquarters in Foster City, California. **Sr Director, CMC Regulatory Affairs -Small Molecules** **KEY RESPONSIBILITIES** The...members to provide one CMC RA voice to PDM project teams regarding regulatory strategy and technical… more
- Taiho Oncology (Princeton, NJ)
- … regulatory correspondence with Health Authorities. + Member of the Global Project Team to represent Regulatory Affairs for assigned projects/products. ... Associate Director, Regulatory Affairs Strategy Pleasanton, CA, USA...two high priority late-phase clinical development programs as Global Regulatory Lead (GRL), responsible for leading … more
- ICON Clinical Research (Farmingdale, NY)
- …and have regulatory project management experience. The role: As a Regulatory Affairs Manager you will need to be experienced with In Vitro Diagnostic ... lead or work as part of an internal regulatory or cross-functional team depending on the size and... project . You will also contribute to ICON Regulatory Affairs through your understanding of FDA… more