- Teleflex (Morrisville, NC)
- Regulatory Affairs Team Lead **Date:** May 8, 2025 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 25% **Requisition ... Lead and manage day to day activities and regulatory staff * Support regulatory activities which...other highly regulated environments * Minimum of 3 years regulatory affairs /compliance leadership experience **Specialized Skills /… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the business. This ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment....to work as part of the regulatory team to meet group objectives and to lead… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead . Translates complex pertinent global requirements and provides an ... associated regulatory challenges to the GRL, global regulatory team , assigned project teams, and internal/external... regulatory activities in alignment with the Global Regulatory Lead (GRL). - Identifies the need… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …guidance and perspective to the cross-functional team in conjunction with global regulatory lead (s). + Prepare, coordinate and/or review all CMC and GMP ... investigational filings and approvals of marketing applications as the CMC Regulatory lead + Regulatory experience in handling controlled substance… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …brand objectives. Work with other relevant internal stakeholders (eg, Brand Teams, Regulatory Affairs , Market Access, Legal, Clinical) to help anticipate, ... We are seeking a Senior Director, Federal Government Affairs to lead our US federal...political program. Ensure all activities are following Otsuka policy, regulatory , and legal obligations. Team Leadership &… more
- Western Digital (Raleigh, NC)
- …in Washington, DC The position will report to the Vice President, Government Affairs , Securities and Corporate Governance. **Responsibilities** + Lead and grow a ... Western Digital is seeking a Vice President of Government Affairs and Policy to build an impactful government relations...Policy to build an impactful government relations program and team to advance the company's public policy agenda and… more
- UNC Health Care (Chapel Hill, NC)
- …Administrative Leadership: + Provide strategic direction and leadership for the academic affairs team , ensuring alignment with departmental objectives + Develop ... well-being of the unique communities we serve. Summary The Director of Academic Affairs will play a pivotal leadership role in managing and overseeing all aspects… more
- Merck (Raleigh, NC)
- …health systems accounts + Serves as a resource for the HSO MAD Team Lead , HSO Executive Director Medical Affairs , and other members of Country Medical ... in a balanced and credible manner consistent with the regulatory environment and company's ethical standards. This role also...role also serves as a resource for the Medical Affairs (MA) management team on strategic planning… more
- Veterans Affairs, Veterans Health Administration (Durham, NC)
- …of and complies with applicable standards, policies, procedures, and regulatory requirements. Provides guidance and mentorship to expand professional knowledge ... vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Qualifications Basic Requirements: United States… more
- Merck (Raleigh, NC)
- **Job Description** The Director/Principal Scientist, Regulatory Affairs Liaison, is responsible for the development and implementation of worldwide ... approval for all submissions and associated documentation. Provide expertise as the Global Regulatory Lead to Product Development Teams and the regulatory … more
- Highmark Health (Raleigh, NC)
- …/ accreditation requirements through collaboration with Business Units accountable for government affairs , regulatory affairs , and/or regulatory ... feel comfortable working in a highly matrixed environment. **ESSENTIAL RESPONSIBILITIES** + Lead project and initiatives involving a global team of specialists.… more
- Cardinal Health (Raleigh, NC)
- …capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing and Controls Development + Nonclinical ... **Position Summary** For nearly five decades, Cardinal Health Regulatory Sciences' industry-trained regulatory consultants have...bring Cardinal Health to the table, build relationships, and lead the sales process to a close with a… more
- Chiesi (Cary, NC)
- …regional sales managers, corporate account managers, marketing, market access and regulatory team for advancement of medical/strategic objectives to ensure ... Who we are looking for Purpose + As West Lead of the AIR field medical team ,...to serve as the organizational conduit between US Medical Affairs management and our AIR field based medical science… more
- Chiesi (Cary, NC)
- …and nurture relationships with key customers and respiratory OLs. + Build and lead a high-performing team of TLLs including providing strategic direction, ... looking for Purpose We are searching for an experienced Lead HCP Marketer to join our growing US AIR...HCP Marketer to join our growing US AIR Marketing Team . This newly created position will initially focus on… more
- Truist (Raleigh, NC)
- …disabilities to perform the essential functions. + Bachelor's degree preferably in regulatory affairs , business, organizational or compliance law, or financial ... management compliance gaps, partners in the analysis of legal, regulatory and compliance initiatives. Manages cybersecurity risk and compliance functions… more
- Sumitomo Pharma (Raleigh, NC)
- …its differentiated position in a competitive market. The Senior Director will lead a high-performing team of marketers spanning HCP, omnichannel, ... and growth plan for Orgovyx, setting clear direction and partnering closely with your team to deliver high-impact execution. + Lead and develop a high-performing… more
- Sumitomo Pharma (Raleigh, NC)
- …EMA) during IND submissions, clinical study reports, and NDA/MAA filings. + Collaborate with regulatory affairs team to ensure compliance with regulatory ... budget for Oncology clinical development activities. + Partner with Translational Research, Regulatory Affairs , Clinical Operations, and Medical Affairs to… more
- Teleflex (Morrisville, NC)
- …product performance, and life cycle progression. o Work with R&D, Clinical & Medical Affairs (CMA) and Regulatory Affairs (RA) to conduct technical ... to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that… more
- BASF (Research Triangle Park, NC)
- …of the product and preparing a thorough Safety Assessment. + Advising Research, Regulatory Science and Regulatory Affairs of developments and requirements ... the development of strategies and work programs to address regulatory requirements related to allergenicity and toxicity from ...skills, and the ability to work with and indirectly lead a global multidisciplinary team to accomplish… more
- Sumitomo Pharma (Raleigh, NC)
- …supplies on multiple clinical programs. In addition, working closely with CMC, Regulatory Affairs , Quality Assurance, Clinical Operations, and /or SMPA external ... federal, and/or local regulations. + Collaborate closely with Clinical Operations, CMC, Regulatory Affairs , QA, and PDM to ensure advancement of clinical… more