- Insmed Incorporated (NJ)
- …QC of regulatory documents prior to submission.Ensure adherence to global regulatory authority technical requirements ( FDA , EMA, Health Canada, MHRA, etc.) ... submission trackers, and regulatory archives.Partner with cross-functional teams ( Regulatory Affairs, CMC, Clinical, Quality ) to facilitate document… more
- Insmed Incorporated (NJ)
- …for documentation review prepared by other technical functions and will act as the primary regulatory contact for the US FDA . The GRL will be accountable for ... submissionsProvide oversight for preparation and delivery of materials for regulatory agency meetingsPrepare and deliver high- quality presentations for both… more
- ITG Brands (Greensboro, NC)
- …tobacco and nicotine products. Serve as a strategic legal advisor on FDA regulatory matters, including product submissions, labeling, marketing, enforcement, and ... regulatory industry (tobacco, pharmaceuticals, medical devices). + Strong background in FDA regulatory matters, state- regulatory compliance, regulatory… more
- GRAIL (Atlanta, GA)
- …advanced degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions ... Quality , Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market… more
- Post Holdings Inc. (Lakeville, MN)
- …R\&D, and Quality teams. + Support commercialization efforts by ensuring regulatory readiness from concept to shelf. + Educate internal teams on competitive ... **Brand:** Post Consumer Brands **Categories:** Quality **Locations:** Lakeville, Minnesota **Position Type:** Regular Full-Time **Remote Eligible:** Yes **Req ID:**… more
- Terumo Neuro (Aliso Viejo, CA)
- …for submission activities focused on US/EU/Canada and for ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and ... **13011BR** **Title:** Principal, Regulatory Affairs **Job Description:** Responsible for establishing, preparing,...+ Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as… more
- Teleflex (Wyomissing, PA)
- …Regulatory Affairs (RA) Associate will be responsible for a variety of regulatory activities to meet submission, departmental, and quality system compliance ... regulatory impact assessments. Communicate the impact and support required for regulatory activities. - Update applicable quality system procedures to ensure… more
- Takeda Pharmaceutical (Social Circle, GA)
- …Specialist, you will ensure all fractionation operations comply with corporate policies, regulatory requirements (GMP, FDA , EMEA), and safety practices. The ... specialist works closely with cross-functional teams to ensure efficient, high- quality , and compliant production of plasma-derived products. How you will contribute:… more
- Teleflex (Wyomissing, PA)
- …control processes, agile systems, and creation of design documentation. - Solid knowledge of regulatory and quality standards ( FDA 21 CFR Part 820, ISO ... Acting as a subject matter expert, this position collaborates across functions, supports quality and regulatory initiatives, and represents R&D in internal and… more
- Post Holdings Inc. (St. Louis, MO)
- …strategies and processes + Oversee and direct the legal aspects of all FDA , USDA, State Attorneys General, and international regulatory authority related matters ... + Counsel business teams on the development and management of the regulatory and quality documentation infrastructure + Oversee and direct the legal aspects of… more
- Parexel (Augusta, ME)
- …and evaluating clinical sections of regulatory applications. + Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master ... shape it. As a **Senior/Vice President, Technical** on our Regulatory Strategy (RS) team, you'll be at the forefront...activities as well as facilitate business decisions + Produces quality work that meets the expectations of RS and… more
- The Clorox Company (Durham, NC)
- …cross-functional collaboration is essential, involving teams across Product Safety & Regulatory Affairs (PS&RA), Product Development, Legal, Corporate Quality , ... System. **Cross-Functional Collaboration** + Lead cross-functional collaboration with R&D, Legal, Quality , and Marketing teams. + Provide regulatory guidance… more
- Parexel (Juneau, AK)
- …Consultant level role, 7+ years for a Senior Consultant - Proven success in preparing regulatory documentation for FDA , EMA, and Health Canada (IND, NDA, DMF) - ... opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …compliance, clinical quality , or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell based products as well as ... multiple myeloma.Legend Biotech is seeking Head of Compliance as part of the Global Quality team based in Raritan, NJ. Role OverviewThe Head of Compliance will be… more
- Merck & Co. (Rahway, NJ)
- …process inefficiencies using operational excellence tools and ensuring alignment with global regulatory requirements (eg, FDA 21 CFR Part 820, ISO 13485, ... cross-function teams to improve processes related to device-drug integration. Partner with Quality and Regulatory teams to ensure compliance with applicable… more
- Endo International (St. Louis, MO)
- …sites in the area of Quality Systems, and Training. + Interfaces with FDA and regulatory agencies outsite the US for events that include but are ... ensure that all manufacturing, testing, packaging, storage, and distribution activities meet regulatory standards and deliver the highest product quality . The… more
- Caris Life Sciences (Phoenix, AZ)
- …and services issued are identified, resolved, and prevented in alignment with regulatory and internal Quality Systems requirements. The Analyst partners ... Quality Event records in alignment with Caris' Quality System procedures and applicable external requirements ( FDA...CFR, ISO 13485, CAP/CLIA, PMDA, CMDCAS, and other global regulatory frameworks). + Lead investigations for Quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …compliance, clinical quality , or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell based products as well as ... in the treatment of multiple myeloma.Legend Biotech is seeking a Senior Director of Quality Operations as part of the Quality team based in Raritan, NJ.Role… more
- ValSource, Inc. (Rahway, NJ)
- …at client sites, ensuring that pharmaceutical manufacturing processes and systems meet regulatory and quality standards. This role involves extensive travel to ... validation and equipment qualification activities, and ensuring compliance with FDA , GMP, and other regulatory requirements. ResponsibilitiesOn-Site Project… more
- Caris Life Sciences (Irving, TX)
- …maintenance activities for SiMD and SaMD products are in accordance with internal SOPs, Quality System Requirements which include ISO 13485, FDA QSR, IVDR, SOX, ... and applicable Software Validation Planning documents in alignment with FDA QSR, 21 CFR Part 11, and GAMP5 regulation...Part 11, and GAMP5 regulation requirements. + Collaborates with regulatory partners as a software quality subject… more
