Collecting information
Organizing data
As a dedicated Advocacy Advisor-Intermediate , you will within defined guidelines and framework, provide timely , accurate and compliant responses for complaints identified and addressed to USAA's Executive Management Group, Chairman and Board of Directors, general consumers, and/or regulatory agencies.. This position can be based in one of the following locations: San Antonio, TX, Phoenix, AZ, Colorado Springs or Tampa, FL. Relocation assistance is not available for this position.. Risk and Root cause analysis background (efficient and effective research capabilities-de-escalation background beyond live phone calls, i.e. outbound campaigns, remediation efforts, etc. Compensation: USAA has an effective process for assessing market data and establishing ranges to ensure we remain competitive.. You are paid within the salary range based on your experience and market data of the position.
Process and Organizational Effectiveness.. Take personal responsibility for the Notification of Regulatory activities and related database entry/data accuracy for allocated projects. At least three-year experience working in a medical device manufacturing company, preferably with capital medical equipment, highly desired. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
The Executive Director, CMC Regulatory Affairs is responsible for developing and directing the regulatory CMC strategy, objectives, and programs pertaining to development and marketing of drug products.. Lead teams with regulatory CMC responsibility for support of development, registration and life cycle support, and CMC regulatory strategy for United States and EU. Creates and implements CMC regulatory strategies for CTA submissions and marketing applications.. Provides proactive guidance to internal groups (Quality, Manufacturing, etc) based on technical and CMC regulatory knowledge towards development of strategic and tactical plans.. BS, BSc, MS, MSc, PhD, PharmD, in science or healthcare preferred or equivalent relevant experience.
Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.. Agios Pharmaceuticals is searching for a dynamic Associate Director, Regulatory Affairs Strategy to join our growing Regulatory team.. Sr Regulatory Affairs Specialist. Sr. Manager/Associate Director, Regulatory Affairs Strategy and Labeling. Senior Consultant - Regulatory Operations Software Implementation (Remote)Senior Consultant - Regulatory Operations Software Implementation (Remote)Associate Director, Global Labeling Devices
WHOOP is seeking a Quality Systems & Regulatory Affairs Manager (Medical Devices) to navigate and manage regulatory and quality system processes for Medical Device Software. As a Quality Systems & Regulatory Affairs Manager, you will be responsible for various regulatory & quality functions, such as leading regulatory submissions, implementation of quality system post-market processes, collaborating with the WHOOP Medical Device Team throughout the product development process, and ensuring compliance with the Quality Management System (QMS). Implement and manage post-market surveillance, including complaint handling, adverse event reporting (MDR), and field actions.. Bachelor’s Degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, or related field, or equivalent practical experience.. Nice to Have: Experience with Consumer Wearable Products, General Wellness Products, Digital Health or Mobile Medical Applications
Senior Regulatory Affairs Specialist, NPD. Join to apply for the Senior Regulatory Affairs Specialist, NPD role at Kelly Science, Engineering, Technology & Telecom.. Kelly Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a one-year contract with a leading molecular diagnostics company based in Sunnyvale, CA. This role offers an opportunity to contribute to cutting-edge scientific advancements and advance your career in biotechnology.. Position Title: Senior Regulatory Affairs Specialist, New Product Development. Evaluate and ensure labeling accuracy for Cepheid’s in vitro diagnostic products.
Regulatory Affairs Consultant, Orphan Drug. We are looking for a Regulatory Affairs Consultant to support several ongoing regulatory submission programs.. Work closely with Pharmatech and our client’s project team to be responsible for the execution of the regulatory operations related to the Lorenz docuBridge TWO submission management software relating to FDA communication and submission of regulatory documentation.. Fast Track and Orphan Drug applications for regulatory submissions to the FDA (or other regulatory agencies).. Advanced degree from accredited college or university in science, biomedical engineering, plus a minimum of 4 years of experience in Filing Global Regulatory Applications for pharmaceutical and Biotech products using the Lorenz docuBridge TWO submission management software.
Regulatory Affairs Specialist - Post Market - req1434.. Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is responsible for complaint handling, coordination of product recalls, FMI processes, processing electronic submissions and state registrations. Assist in maintaining proper preparedness for State or Federal (FDA) authorities.. 2 Years Regulatory Affairs experience in medical device industry required.. Canon Medical Systems USA, Inc., a world leader in diagnostic imaging, is in search of qualified candidates to fill our open positions.
We believe that blockchain and digital asset innovation will transform how value moves through the world and were building the products and services to make that future a reality.. Our institutional digital assets platform spans trading, investment banking, asset management, staking, self-custody, and tokenization technology.. Led by CEO and Founder Michael Novogratz, our team blends deep crypto expertise with institutional experience and a shared commitment to shaping the future of Web3 and AI. In addition to ensuring compliance, you will attend Independent System Operator (ISO) or Public Utility Commission (PUC) stakeholder meetings, workshops, and discussions to advocate for Galaxys position within the relevant market.. Direct, recent experience within the ERCOT and PUCT stakeholder environment
Ensure Exelixis development and commercialized products are manufactured in accordance with approved chemistry, manufacturing and control (CMC) requirements. Provide CMC Regulatory expertise for commercial and development projects. Work closely with the PSC/CMC, Regulatory Affairs, and Quality Assurance departments, as well as with cross-functional project teams. Liaise internally with other members of the Regulatory Affairs department to coordinate CMC changes with other aspects of the development programs. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
Kellen is an association management firm seeking an experienced professional to serve as a Senior Manager/Director of Technical and Regulatory Affairs to support clients in the food industry.. The ideal candidate will have a strong background in food science, nutrition, and regulatory affairs, with demonstrated experience navigating the regulatory landscape.. Monitor and develop comments to relevant scientific, nutrition, and regulatory policy proposals, and recommend actions, as needed, engaging with appropriate client groups on final industry positions in response to government agencies (e.g., Food and Drug Administration, U.S. Department of Agriculture).. Bachelor’s degree or higher in a discipline related to science (e.g., food science, nutrition, public health) or a related field, and 5-7 years’ related field experience is desired.. This job can be located in Washington, D.C or Chicago, IL. Kellen operates in a hybrid working environment (i.e., working both in the office every Tuesday and Wednesday and remotely other days of the week).
Join to apply for the Associate Director of Regulatory Affairs role at Alliance Clinical Network.. SUMMARY: The Associate Director of Regulatory Affairs is responsible for managing the efficient execution of all regulatory functions across multiple clinical trials, providing strategic direction, resource allocation, and leadership to the regulatory team. Legal Director - Technology Innovation Counsel.. Director of eDiscovery and Litigation SupportVice President of Quality and Regulatory Affairs.. Director Clinical and Regulatory Counsel - IrvingVP, Regulatory Intelligence & Compliance
Senior Regulatory Affairs Manager - Oncology.. Senior Regulatory Affairs Manager – Oncology.. Bachelor’s degree in Life Sciences, Engineering, or related discipline with at least 7 years of relevant regulatory affairs experience in an IVD regulatory affairs role, preferably in molecular diagnostics or closely related area; OR an advanced degree with at least 5 years of relevant experience in an IVD/CDx regulatory affairs role. Proven success in authoring and leading FDA regulatory submissions and interactions, including PMAs, sPMAs, 30-Day Notices, 510(k)s, and IDE submissions. GH will consider qualified applicants with criminal arrest or conviction histories in a manner consistent with applicable law including but not limited to the LA County Fair Chance Policies and the Fair Chance Act (Gov. Code Section 12952).
We have marketed a range of products across therapeutic categories, including ANTARA (fenofibrate) and METHERGINE (methylergonovine maleate), as well as launching Inspira Chamber (valved holding chamber), Brovana Inhalation Solution, and Xopenex HFA. While these brands treat a wide range of medical conditions, they have one important commonality: they are part of a sincere effort to broaden the treatment landscape for the benefit of patients and providers alike.. We are building our specialty business in therapeutic areas where we have synergy, including respiratory and neurological diseases.. Evaluate competitive landscape and various regulatory mechanisms that allow optimization of product development (e.g., orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, pediatric plans) and present options and recommendations to expedite the path to market, as applicable.. MSc level degree preferably within the life sciences (PharmD, PhD preferred). Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Inhalation and Neurology and Other therapeutic areas)
Clinical Trial Regulatory Affairs Specialist (Boston, MA) Hybrid role. Regulatory Compliance: Ensuring all clinical trials adhere to applicable regulations and guidelines, including FDA, EMA, and ICH standards.. Experience: A minimum of 10 years in regulatory affairs within the biotechnology or pharmaceutical industry, with direct involvement in clinical trial regulatory processes.. Knowledge: Strong understanding of clinical trial regulations, Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and ethical standards.. Education: Bachelor’s or master’s degree in regulatory affairs, life sciences, or a related field.
Who We Are: Galaxy is a global leader in digital assets and data center infrastructure, delivering solutions that accelerate progress in finance and artificial intelligence.. We believe that blockchain and digital asset innovation will transform how value moves through the world – and we’re building the products and services to make that future a reality.. We are seeking an experienced regulatory affairs and compliance specialist to join the Galaxy Data Centers team where you will assist in ensuring compliance with grid related market rules or statutes for data centers.. In addition to ensuring compliance, you will attend Independent System Operator (“ISO”) or Public Utility Commission (“PUC”) stakeholder meetings, workshops, and discussions to advocate for Galaxy’s position within the relevant market.. Direct, recent experience within the ERCOT and PUCT stakeholder environment
Product Owner Global Regulatory Affairs (m/f/d) City: Various Locations. Minimum 8 years of experience, working in life science technology environment, preference in scientific technology. Good understanding & experience with RIM Functional Processes – Registrations Management, Submission Planning, Submission Content Planning, Document Management, Publishing etc.. As a science-based, privately-owned pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide.. Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America and the US. Our products are available in more than 100 countries.
Licensing and Regulatory Affairs Manager Join to apply for the Licensing and Regulatory Affairs Manager role at American Credit Acceptance. Join to apply for the Licensing and Regulatory Affairs Manager role at American Credit Acceptance. About the Role: The Licensing and Regulatory Affairs Manager will lead ACA's Licensing and Examinations Program within the Legal department, reporting to the Assistant General Counsel.. 5+ years of demonstrated experience as a corporate Legal Analyst, Paralegal, or Legal Specialist.. Get notified about new Regulatory Affairs Manager jobs in Spartanburg, SC.
Participate in industry associations and develop leadership positions for Liberty Utilities. Through our operating business (Liberty), we provide regulated electricity, water, and natural gas utility services to over 1 million customer connections, primarily in North America. And, our growing portfolio of clean, renewable wind, solar, hydro and thermal power generation facilities represent over 3 GW of renewable generation capacity in operation and under construction. Sign in to set job alerts for “Regulatory Affairs Manager” roles. Senior Regulatory Affairs Specialist (Memphis, TN)
This position is responsible for all regulatory affairs and rates related functions in multiple jurisdictions.. The Manager will support the Regional Director, on other regulatory matters and organizational strategies on a periodic basis.. Provide regulatory leadership and advice to direct and indirect reports to ensure regulatory compliance and to maximize earnings at the local state level.. Leads project planning and analysis preparation in support of major rate cases, as well as pre-filed testimony and exhibits.. Defined Contribution savings plan