- Aldevron (Miami, FL)
- …Quality and release processes in compliance with all foreign and domestic regulatory and statutory requirements. This individual will help to provide the strategic ... as the site's primary contact with both customers and regulatory agencies regarding quality/compliance issues and Negotiate Quality AgreementsDevelop and… more
- American Express (New York, NY)
- …Qualification:** + Master's degree in Finance/Accounting. CPA is a plus. + Knowledge of regulatory audit or process review is a plus. **Qualifications** ... team is responsible for ensuring governance and oversight of regulatory reporting process . The team performs Quality...to:** + Lead Quality Assurance reviews which include: + Process review to identify control gaps and… more
- Genesis Healthcare (NM)
- …Advisor is responsible for overseeing Regulatory compliance and the Quality Review process that supports compliance to state and federal regulations, as ... Review . 6. Will ensure the approved Quality Review process will be followed accordingly and...and present training sessions for Market related to survey process , regulatory guidelines and any other related… more
- Abbott (Alameda, CA)
- …questions and negotiate with regulatory agencies during the submission review process to obtain submission approval, working with in-country affiliates ... of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submission to authorities in Canada and… more
- Astellas Pharma (Northbrook, IL)
- …and compliant by owning projects and gaining approval through the Medical, Legal and Regulatory review process . + Manage outside agencies in HCP tactical ... impactful action plans + Experience owning projects through the Medical, Legal and Regulatory review process , preferably for a partnered product + Ability to… more
- Astellas Pharma (Northbrook, IL)
- …and compliant by owning projects and gaining approval through the Medical, Legal and Regulatory review process . + Manage outside agencies in HCP tactical ... impactful action plans + Experience owning projects through the Medical, Legal and Regulatory review process , preferably for a partnered product + Ability to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of modular content with cross functional reviewers in the medical, legal, and regulatory (MLR) review process , identifying opportunities for efficiency. ... and leveraging technology such as authoring tools and workflow review tools like Veeva Vault to drive a reuse...and compliant. + Work closely with medical, legal, and regulatory teams to define content modules and ensure their… more
- Takeda Pharmaceuticals (Boston, MA)
- …Legal, and Regulatory review functions within the Commercial Material Review Process (CMRP). Provide regulatory guidance during development, ... for prescription medicines. + Experience in prescription medicine promotion development and review process . + Strong interpersonal skills with ability to… more
- Abbott (Lake Forest, IL)
- …stakeholders. + Negotiate with regulatory authorities during the development and review process to ensure submission approval. + Provide strategic input and ... guidelines of the regulatory profession, clinical research, and regulatory process . Apply Now (https://www.jobs.abbott/us/en) * Participants who complete… more
- Abbott (Santa Clara, CA)
- …Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval. **Postmarket:** + Maintain annual ... Monitor impact of changing regulations on submission strategies. + Monitor applications under regulatory review . + Monitor and submit applicable reports to … more
- Caris Life Sciences (Tempe, AZ)
- …and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance. + Advise personnel on ... Author and update SOPs, recommend timely changes to ensure regulatory compliance, and lead process improvements to...product concepts to make recommendations on future actions. + Review of advertising and promotional items. + Assist in… more
- Medtronic (Lafayette, CO)
- …negotiations and interactions with regulatory authorities during the development and review process + Provide business and product information to the ... Monitoring Operation unit. Activities include participation in change development projects, review and approve design control documentation, regulatory change… more
- Abbott (Sylmar, CA)
- …+ Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval + Provide strategic input and ... submission strategies and update internal stakeholders + Monitor applications under regulatory review + Communicate application progress to internal stakeholders… more
- Abbott (Plymouth, MN)
- …Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval. + Manage and execute preapproval ... submission strategies and update internal stakeholders. Monitor applications under regulatory review . Communicate application progress to internal stakeholders.… more
- J&J Family of Companies (Santa Clara, CA)
- …negotiate directly with regulatory authorities during the development and review process to ensure submission approvals. + Communicate application progress ... and IEC standards, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents). + Review and..._Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If… more
- J&J Family of Companies (Santa Clara, CA)
- …negotiate directly with regulatory authorities during the development and review process to ensure submission approvals. * Communicate application progress ... and IEC standards, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents). * Review and..._Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If… more
- Abbott (Alameda, CA)
- …actions. + Negotiate with regulatory authorities during the development and review process to ensure submission approval. + Write and edit technical ... + Represent regulatory affairs in product recall and recall communication process in APAC. + Provide strategic input and technical guidance on regulatory… more
- Edwards Lifesciences (Irvine, CA)
- …project(s), propose suggestions on utilizing regulatory updates to expedite approval process + Review labeling content product and process changes, ... inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review ...with regulatory agencies as part of submission review and on-site audit support. (eg, IDE's, PMA's, annual… more
- Stantec (Hampton, VA)
- …contributing to environmental assessments/impact statements pursuant to NEPA. + Experience in the regulatory review process for the biological component of ... range of audiences/technical backgrounds including internal and external clients and regulatory agencies. + Exceptional organizational skills and ability to work… more
- Abbott (Alameda, CA)
- …enforcement actions. + Negotiate with regulatory authorities during the development and review process to ensure submission approval. + Review and ... monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory … more
