- Fidelity TalentSource LLC (Boston, MA)
- …able to effectively lead all aspects of production process and communicate project goals and articulat the "why" behind your ideas to people with differing ... The TeamThe Creative Solutions team sits within Fidelity's Corporate Affairs Organization. Our environment is fast-paced, ultra-collaborative, and ever-changing. We… more
- Gilead Sciences, Inc. (Foster City, CA)
- …headquarters in Foster City, California. **About the Role:** The Senior Director, CMC Regulatory Affairs for Biologics is responsible for leading a matrix team ... in Gilead's global portfolio of biological products in CMC Regulatory Affairs . This position will provide leadership...licensure and right to operate of Gilead's operations. + Lead the execution of these global CMC regulatory… more
- Meta (Seattle, WA)
- …a medical device (SaMD). **Required Skills:** Head of Medical Devices Regulatory Affairs Responsibilities: 1. Lead project teams for end-to-end ... **Summary:** Reality Labs is seeking an experienced medical devices regulatory affairs professional to lead the regulatory strategy and product approvals… more
- Philips (Chicago, IL)
- …proposal for balancing the project risk to project teams and Regulatory Affairs Management. + Lead communication and negotiation efforts with ... The Principal Regulatory Affairs Specialist will play a...Lead business critical new product development projects, provide regulatory oversight to maintain lifecycle ensuring that the state-of-the-art… more
- J&J Family of Companies (San Lorenzo, PR)
- Senior Regulatory Affairs Program Lead (Biosurgery) - Ethicon, Inc. - 2406206427W **Description** **Ethicon Inc** ., part of Johnson & Johnson MedTech, is ... recruiting for a **Senior Regulatory Affairs Program Lead ** to...independently and collaborate with a large team to achieve project success. * Excellent written and verbal communication skills.… more
- Astellas Pharma (Northbrook, IL)
- …activities. The individual will have interactions inside and outside of the Regulatory Affairs department, including with members of senior management, on ... of key stakeholders responsible for advertising and promotion review. 8. Collaborates within Regulatory Affairs to ensure that contents of promotional and sales… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …our team. It's a great time to be a part of ZOLL!Job SummaryThe Senior Regulatory Affairs Program Lead is responsible for managing the collaboration with ... ensure regulatory compliance is met. The Senior Regulatory Affairs Program Lead will...and compliance activities. Knowledge, Skills and Abilities + Exemplary project management skills. Expert ability to prioritize, conduct, and… more
- Edwards Lifesciences (Irvine, CA)
- …division. As a Manager in the Clinical, Medical, and Regulatory Affairs Program Management Office, you will lead multiple cross-functional clinical trial ... you'll make an impact:** + Planning: Develop multi-level, detailed project plans to meet clinical, medical and regulatory...tact and professionalism, and effectively manage conflict to maximize project team progress + Ability to lead ,… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …team of Clinical Regulatory Affairs professionals providing strategic regulatory guidance to cross-functional project teams and responsible for product ... alignment with overall development plan. + Is assigned as lead contact with FDA and Health Canada or delegated...as a key member of Global Regulatory Project Teams; and represents Regulatory Affairs… more
- Merck (Rahway, NJ)
- …Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This includes ... for business process management and continuous improvement. + Establish and lead assigned domain Global Process Control Boards (GPCBs), accountable for successful… more
- ThermoFisher Scientific (Fremont, CA)
- …regulatory compliance. * Implement policies, procedures, practices and strategies for Regulatory Affairs . * Collaborate with International RA, R&D, Marketing, ... labeling, training, promotional, and advertising material. * Maintenance of Regulatory Affairs product files and ensure compliance...De Novo, and technical files for CE marking. * Lead a team to support global regulatory … more
- Medtronic (Minneapolis, MN)
- … Regulatory Affairs ; Strategy Planning, US and major market regulatory requirements, project management, and negotiations + Demonstrated ability to work ... a remote worksite may be considered. The **Senior** **Principal Regulatory Affairs ** will play a key role...activities to launching new products and sustain the current regulatory activities that lead to and maintain… more
- Portland General Electric (Portland, OR)
- …emails to appropriate internal stakeholders. Oversee the tracking of dockets and regulatory affairs calendar and prepares and maintains an accessible ongoing ... the OPUC filing process **Compliance** Primary DevonWay coordinator within regulatory affairs for all new OPUC orders...basis. Serves as subject matter expert on projects. May lead OPUC document-related projects. Supports the needs of the… more
- AbbVie (Irvine, CA)
- …projects. Executes US regulatory strategic plans and provides guidance to Global Regulatory Lead (GRL) and project team. Plans and prepares complex ... Allergan Aesthetics on LinkedIn. Job Description Description The Manager Regulatory Affairs represents US regulatory ...strategies and policies. Duties and Responsibilities: + Represents US Regulatory in project teams. Develops US … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … Regulatory Affairs (Early Development) provides strategic global regulatory guidance to cross-functional project teams responsible for product ... guidelines. + Leads as a key member of Global Regulatory Project Teams. + Leads multidisciplinary team...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Boehringer Ingelheim (Ridgefield, CT)
- … strategy expertise/knowledge in one or more therapeutic areas. Interact effectively within Regulatory Affairs and across functions, as a US regulatory ... common goals for assigned projects, with supervision. With supervision, the Product Group Regulatory Affairs Fellow will: + Regulatory Professionalism: + As… more
- Kelly Services (Alameda, CA)
- …on the client and advise Regulatory Affairs leadership accordingly. + Lead Regulatory Affairs action planning of updates to policies, processes and ... ** Regulatory Affairs Policy, Intel, & Compliance...potential issues. + Designs and implements solutions to address project level challenges, taking into consideration the broader impact.… more
- Ascendis Pharma (Palo Alto, CA)
- … regulatory affairs experience in the biopharmaceutical industry. + Oncology regulatory experience a plus. + Effectively lead teams in preparation of ... all aspects of the business, from drug development to marketing. The Senior Manager, Regulatory Affairs will be responsible for supporting and developing global … more
- Medtronic (Boulder, CO)
- …in a more connected, compassionate world. **A Day in the Life** The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for collaborating, planning and ... and review process + Provide business and product information to the international regulatory affairs team to enable development and strategies and requirements… more
- Mondelez International (East Hanover, NJ)
- …job application process may contact ### for assistance. **Job Type** Regular Scientific Affairs & Regulatory Affairs Product Quality, Safety and Compliance ... It Happen at Mondelēz International?** **Join our Mission to Lead the Future of Snacking. Make It With Pride.**...Pride.** The Sr. Scientist II will execute the Scientific Affairs Strategy for your respective categories and geographical area… more
