Senior Regulatory Affairs Associate - Generalist Parexel International CorpSenior Regulatory Affairs Associate - GeneralistNCThis role is dedicated to providing end‑to‑end regulatory affairs support for partnered assets, working closely with internal teams and external alliance stakeholders to ensure regulatory excellence across clinical, submission, and post‑approval activities. Serving as a key regulatory interface within the partnership, the Regulatory Affairs Generalist / Senior Associate plays a critical role in regulatory planning, documentation management, submission execution, and ongoing compliance with global regulatory requirements.
Plasma Regulatory Affairs Associate Grifols SAPlasma Regulatory Affairs AssociateNCExample: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
Regulatory Affairs Specialist (CMC) Zp Group LlcRegulatory Affairs Specialist (CMC)Durham, NC$60,000–$85,000 / yearThe Regulatory Affairs Specialist is responsible for supporting global regulatory activities related to product development, registration, and lifecycle management of pharmaceutical products. This role ensures compliance with applicable regulatory requirements and provides strategic and operational support for CMC documentation and submissions across multiple regions.
Regulatory Affairs Associate/Senior Associate Azurity PharmaceuticalsRegulatory Affairs Associate/Senior AssociateRaleigh, NCAs an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The Regulatory Affairs Associate/Senior Associate will report to the Associate Director, Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Technical Operation, Quality Assurance, Clinical Development, Medical Affairs.
Regulatory Affairs Associate/Senior Associate Azurity Pharmaceuticals IncRegulatory Affairs Associate/Senior AssociateRaleigh, NCAs an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The Regulatory Affairs Associate/Senior Associate will report to the Associate Director, Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Technical Operation, Quality Assurance, Clinical Development, Medical Affairs.
Associate Director Regulatory Affairs, Oncology GSK plcAssociate Director Regulatory Affairs, OncologyDurham, NC$138,750–$231,250 / yearThis role will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile.
Regulatory Affairs Specialist Zp Group LlcRegulatory Affairs SpecialistNCCoordinate with cross-functional teams including Regulatory Affairs, Quality, Manufacturing, Technical Operations, and CMC subject matter experts to gather and review submission content. Job Summary: Piper Companies is seeking a Regulatory Affairs Specialist I - CMC to support our end client''s Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs team.
Director, Global Regulatory Affairs Lead (Oncology) GSK plcDirector, Global Regulatory Affairs Lead (Oncology)Durham, NC$171,750–$286,250 / yearProven track record of facilitating groups of individuals to work together on creating solutions and developing regulatory strategies, proactively seeking information and insight from a broad range of sources and weight benefits and risks before making important decisions. Works with the respective GRS TG Portfolio Lead and TG VP to ensure a robust regulatory strategy and appropriate TG resource is in place to support respective development programs to meet the needs of the key markets identified in the IES and the Medicine Profile.
Associate Director or Director, CMC Regulatory Affairs Atsena Therapeutics IncAssociate Director or Director, CMC Regulatory AffairsDurham, NCLead preparation and review of CMC sections of global regulatory submissions, including: INDs and IND amendments, CTAs and IMPDs, BLA/MAA submissions and supplements, annual reports and regulatory updates Ensure submissions meet regulatory expectations for gene therapy products. This role is responsible for developing CMC regulatory strategies across product development stages, supporting regulatory submissions, and serving as the regulatory liaison to internal CMC teams and external contract manufacturing organizations.
Regulatory Affairs Manager - CMC & Labeling United Therapeutics CorporationRegulatory Affairs Manager - CMC & LabelingRaleigh, NCDirect and manage direct reports to include responsibilities for training, goal setting and achievement, performance evaluations/management, coaching, mentoring, career development and provide support for recruitment process (as needed). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need.
Senior / Regulatory Affairs Consultant - Regulatory Labeling Strategist Parexel International CorpSenior / Regulatory Affairs Consultant - Regulatory Labeling StrategistNCAre you experienced in leading the strategy behind how life-changing therapies are communicated to the world, ensuring innovative products are supported by clear, compliant, and high-quality documentation that enables safe and effective use across global markets?. Parexel is seeking an experienced and highly motivated Global Regulatory Labeling Lead to provide strategic leadership and operational oversight for complex global labeling initiatives.
Regulatory Affairs Associate/Senior Associate Azurity Pharmaceuticals - USRegulatory Affairs Associate/Senior AssociateRaleigh, NCAs an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The Regulatory Affairs Associate/Senior Associate will report to the Associate Director, Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Technical Operation, Quality Assurance, Clinical Development, Medical Affairs.
Senior Manager, Regulatory Affairs Azurity PharmaceuticalsSenior Manager, Regulatory AffairsRaleigh, NCBrief team/department description: As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be responsible for overseeing and managing the regulatory activities for assigned products/projects and will serve as the regulatory representative on cross-functional teams for assigned projects. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline.
Senior Manager, Regulatory Affairs Azurity Pharmaceuticals - USSenior Manager, Regulatory AffairsRaleigh, NCAs a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be responsible for overseeing and managing the regulatory activities for assigned products/projects and will serve as the regulatory representative on cross-functional teams for assigned projects. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline.
Senior Manager, Regulatory Affairs Azurity Pharmaceuticals IncSenior Manager, Regulatory AffairsRaleigh, NCBrief team/department description: As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be responsible for overseeing and managing the regulatory activities for assigned products/projects and will serve as the regulatory representative on cross-functional teams for assigned projects. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline.
Director, Regulatory Affairs AskBio IncDirector, Regulatory AffairsNCThis role will provide regulatory direction for preclinical and clinical development of AskBio's product candidates, working closely with cross-functional Regulatory team members, Global Project Teams, subject matter experts, and external partners to ensure regulatory strategies are aligned with applicable health authority requirements and expectations. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson's disease, and Pompe disease.
Sr. Director, Strategic Regulatory Affairs and UDI Teleflex IncSr. Director, Strategic Regulatory Affairs and UDIMorrisville, NC$203,000–$253,000 / yearThe position leads a global organization through a team of managers and functional leaders and serves as a key partner to Regulatory Affairs, Quality, Supply Chain, Manufacturing, Information Technology, Commercial, and Executive Leadership teams to ensure regulatory compliance, support global market access, and enable business growth. The Senior Director, Strategic Regulatory Affairs & UDI provides leadership and oversight for global regulatory operations, regulatory systems, unique device identification (UDI), regulatory data governance, import/export regulatory compliance support, and regional Regulatory Affairs and Quality functions.
Head of US Crop Protection Regulatory Affairs - Research Triangle Park, NC (preferred) BASF SEHead of US Crop Protection Regulatory Affairs - Research Triangle Park, NC (preferred)NCAs a key member of the APD North American Crop Protection leadership team and industry influencer, you will leverage your connections with management in the commercial, supply chain and development functions and apply your understanding of competitive threats, changing regulatory dynamics, and new technologies to set the regulatory direction that facilitates successful business outcomes. Serving as key interface between US Regulatory and key internal BASF stakeholders, proactively facilitating collaboration and coordination to assure strategic alignment and build relationships with stakeholder groups including EPA, USDA, and trade associations, including leadership.
Senior Regulatory Affairs Consultant - Regulatory Project Manager Parexel International CorpSenior Regulatory Affairs Consultant - Regulatory Project ManagerNCYou will be accountable for driving regulatory excellence by aligning cross-functional stakeholders, managing complex timelines, and anticipating challenges to enable successful delivery of regulatory milestones that support sponsor's mission to bring transformative vaccines to patients worldwide. This role is designed for an experienced and forward-thinking regulatory project manager who thrives in a fast-paced, innovative environment and can seamlessly integrate strategic thinking with operational execution across all stages of product development, registration, and post-marketing.
Senior Regulatory Affairs Specialist BioventusSenior Regulatory Affairs SpecialistDurham, NCRequired: Master's degree or foreign equivalent in Regulatory Affairs, Pharmaceutical Sciences or related field plus 3 years of experience in the job offered, as Regulatory Engineer or related regulatory affairs position within the medical and/or diagnostic device industry. Duties: Author and submit applications 510(k), PMA Supplements and, Technical Documentation to receive product clearance / approvals for new products and maintain existing registrations globally.