- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:We're looking for a Manager , Regulatory Affairs , Tactical Implementation, on the Regulatory ... possible for patients with serious diseases. Reporting to the Associate Director, Regulatory Affairs , Tactical Implementation, you'll have a critical role in… more
- Olympus Corporation of the Americas (Westborough, MA)
- …supports the Global Senior Manager to plan and direct the OSTA Core Regulatory Affairs Team activities including but not limited to analysis of requirements ... healthcare beyond traditional medical devices. This leadership role leads an OSTA Core Regulatory Affairs Team and provides world-class regulatory strategies… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …Master's degree in life sciences field (preferred over Bachelor's) RAC certification ( Regulatory Affairs Certification) PMP certification ( Project Management ... This position will be working in BD-Connected Care on Regulatory Affairs projects that support the Pharmacy...to affected organizations across BD. This position may provide Regulatory guidance to project teams, Operations, and/or… more
- Dentsply Sirona (Waltham, MA)
- …enhancing business relationships. Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, ... needed. Education Bachelor's degree in a relevant field, such as life sciences, regulatory affairs , or a related discipline. Regulatory Certification (such… more
- Olympus Corporation of the Americas (Westborough, MA)
- …of a high-growth, innovative team, this position oversees collaboration between internal Olympus Regulatory Affairs Teams and external vendors as needed and will ... Qualifications Required: BS or comparable required. Minimum of 10 years' experience in Regulatory Affairs , ideally within the medical device or digital health… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- Job Summary The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities,… more
- Otsuka America Pharmaceutical Inc. (Phoenix, AZ)
- …experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, quality ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …changed local market authorization holders and distributors. Primary Responsibilities: Act as Regulatory Affairs authority for key product registrations with a ... required) to regulatory authorities. (eg labeling specific projects). Represent the regulatory function on project teams as related to worldwide product… more
- Lowe's (Mooresville, NC)
- Your Impact The primary purpose of the Senior Manager , Regulatory Affairs and Marketplace Compliance is to lead the development and operationalization of our ... and overseeing policies, processes, and controls that ensure compliance with regulatory requirements, internal policies, and industry best practices. The role… more
- ThermoFisher Scientific (St. Louis, MO)
- …safer. A day in the Life: Serve as the primary contact for Site Regulatory Affairs Coordinate regulatory assessments and filing management Provide strategic ... regulatory support to project teams Keys to Success: Outstanding leadership and collaboration...and collaboration skills Proven ability to manage staff and regulatory processes Dedication to achieving flawless compliance Education Bachelor's… more
- Medtronic (Minneapolis, MN)
- …in a more connected, compassionate world. A Day in the Life SENIOR REGULATORY AFFAIRS SPECIALIST In collaboration with leading clinicians, researchers, and ... provide. Therefore, we are looking for a passionate Senior Regulatory Affairs Specialist who has direct experience...to ensure timely approval for market release. Review significant regulatory issues with the manager as necessary,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …more about Life at Olympus: https://www.olympusamerica.com/careers . Job Description The Sr. Regulatory Affairs (RA) Specialist II Digital Health supports ... to regulatory or auditor inquiries as directed. Interface with International Regulatory Affairs Team and drive preparation of dossiers for registration on… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. Position Summary : The Lead Regulatory Affairs Specialist oversees the preparation and submission of regulatory ... timely submissions to FDA Obtains and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA… more
- Cipla (Fall River, MA)
- …the launch of Cipla's respiratory business in the United States. Job Title Project Manager Organization Name InvaGen Pharmaceuticals Location 7 Oser Avenue, ... Remote 8:30 AM - 5:00 PM Responsibilities/ Accountabilities The Project Manager position is a highly visible...commercial, portfolio, R&D technical staff, supply chain management, medical affairs , regulatory affairs , quality assurance,… more
- Takeda Pharmaceuticals (Boston, MA)
- …from quality, process experts, product experts, device experts, and regulatory affairs . Works with supervisor for alignment on project management approach ... employment application is true to the best of my knowledge. Job Description Title: CMC Project Manager Location: Cambridge, MA (Hybrid) About the role: As a CMC … more
- Wolters Kluwer (Philadelphia, PA)
- Job Title: Project Manager - Operations CoE About Wolters Kluwer Wolters Kluwer is a global leader in professional information, software solutions, and services ... accountants, lawyers, and tax, finance, audit, risk, compliance, and regulatory sectors. We help professionals deliver deep impact when...key internal and external stakeholders, is looking for a Project Manager for the Operations CoE team,… more
- ICON Clinical Research (Blue Bell, PA)
- …The role will work with a client focusing on The Strategist, Global Regulatory Affairs CMC is responsible and accountable for: Defining, coordinating and ... future of clinical development. We are currently seeking a Manager , Regulatory Strategy with regulatory ...the communication and flow of regulatory information ( regulatory frame work, scope and project timelines)… more
- Xcel Energy (Minneapolis, MN)
- …the CPD and Major Projects Group, manage collaboration with Corporate Development, Legal, Regulatory Affairs , Supply Chain, Siting & Land Rights, Energy Supply ... proper handover to the project management team for the execution phase. Development Manager - Wind Lead The Development Manager for Wind will lead the… more
- Otsuka America Pharmaceutical Inc. (Oklahoma City, OK)
- …with product strategy and scientific messaging. Collaborate cross-functionally with Medical Affairs , Regulatory , Legal, and Commercial teams to ensure ... The Manager , Medical Core Content is a team-level operational...Act as key support resource for the Field Medical Affairs team, managing the content repository and version control… more
- Fresenius Medical Care North America (Lawrence, MA)
- …desirable Strong collaboration skills and experience working with Clinical, Medical Affairs , and Regulatory teams. Proven ability to develop clinically ... PURPOSE AND SCOPE: The Manager , HCP Marketing is responsible for developing and executing clinically focused marketing strategies to support the education, adoption,… more
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