- Cytiva (Miami, FL)
- …and other functions, and facilitate risk-based decisions.Prepare, update and review regulatory support documentation, including Validation Guides, statements, ... about the Danaher Business System which makes everything possible.The Quality and Regulatory Support Manager for Cytiva is responsible for supporting the… more
- Beckman Coulter Diagnostics (Miami, FL)
- …improvement activities. In addition, the CAPA GPO will also take on the role of CAPA Manager of the Global CAPA Review Board (CRB). This position is part of the ... of the Global Process Owner (GPO) Team and report to the Senior Manager of Global Quality responsible for overseeing various Global Quality Management System… more
- Aldevron (New York, NY)
- …of the Operational Quality Assurance team and report to the Sr. Manager , Operational QA, responsible for Developing and implementing labeling processes and ... procedures and collaborating with cross-functional teams, including Clients, Regulatory Affairs, and Marketing, to develop labeling strategies that align with … more
- Grant Thornton (Charlotte, NC)
- As a Regulatory & Practice Review Seasonal Senior Manager you'll support audit teams for regulatory inspection with all with the resources, environment, ... day-to-day may include: + Supporting audit teams that are selected for regulatory inspection + Communicating and interaction with the firm's regulators + Conducting… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …to make a difference with. **How you'll spend your day** The Manager , Regulatory Affairs will: + Prepare, review and approve regulatory submissions (ie ... Manager , Regulatory Affairs Date: May 30,...response meetings: defining scope, deliverables, and response strategies. + Review and approve change notices, specifications, batch records, standard… more
- Abbott (Plymouth, MN)
- …location for our Electrophysiology division. As a manager , the function of a Manager Regulatory Affairs is to combine knowledge of scientific, regulatory ... submission strategies and update internal stakeholders. Monitor applications under regulatory review . Communicate application progress to internal stakeholders.… more
- Abbott (Sylmar, CA)
- …submission strategies and update internal stakeholders + Monitor applications under regulatory review + Communicate application progress to internal stakeholders ... Management solutions The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our...and clinical documentation for submission filing + Compile, prepare, review and submit regulatory submission to authorities… more
- American Express (New York, NY)
- …+ Master's degree in Finance/Accounting. CPA is a plus. + Knowledge of regulatory audit or process review is a plus. **Qualifications** Salary Range: ... How will you make an impact in this role? The Quality Assurance and Regulatory Governance team is responsible for ensuring governance and oversight of regulatory … more
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Clinical Regulatory Location: Brisbane, California About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology ... treatment for patients suffering from immunological diseases. Position Summary: The Senior Manager , Clinical Regulatory will report to the Director, Clinical … more
- Takeda Pharmaceuticals (Boston, MA)
- …more complex submissions; Provide strategic and tactical guidance to teams, including regulatory review of clinical trial documents and collaborates cross ... the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Manager , Global Regulatory Affairs, Marketed Products **POSITION DESCRIPTION** :… more
- Abbott (St. Paul, MN)
- …and software, vessel closure devices and peripheral stents. **The Opportunity** This ** Regulatory Affairs Project Manager ** position is an onsite opportunity ... Division. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine... submissions as well as interface directly with various regulatory agencies, as required, to facilitate the review… more
- Abbott (Alameda, CA)
- …on submission strategies. + Assess external communications relative to regulations. + Review regulatory aspects of contracts. + Assist with label development ... levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations**...You'll Work On** + Assist in SOP development and review + Provide regulatory input to product… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders **Job Summary:** The Regulatory Process Manager will be a key member of the Global ... Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible...This role will be responsible for coordinating the authoring, review and approval of new or updated procedural documentation.… more
- Liberty Utilities (Londonderry, NH)
- Project Manager , East Region Regulatory Londonderry, NH, US, 03053Londonderry, NH, US, 03053 **Our purpose is sustaining energy and water for life, and it is ... multi-year complex, rate case, audit, and other high profile regulatory projects. The Project Manager will oversee... filing or respond to discovery requests, coordination and review of timely discovery responses and facilitation of successful… more
- American Electric Power (Austin, TX)
- … activity portion of quarterly accounting issues book to management + Draft and review regulatory contingency disclosures for SEC Form 10K, GAAP and FERC ... regulatory activities. Licenses/Certifications: + CPA preferred **_Regulatory Case Manager (Grade 10)_** Education: + Bachelor's degree in accounting, finance,… more
- Rise Baking Company (York, PA)
- …compliance guides, inspection reports, journals, meetings, etc. + Assist the Senior Regulatory Compliance Manager with sustainability customer requests such as ... palm oil and cocoa surveys + Assist Senior Regulatory Compliance Manager with sustainability directives involving regulatory initiatives + Support food… more
- AbbVie (San Francisco, CA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager , RA Global Regulatory Strategy, US & Canada position is ... driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director,...members. + Key contributor responsible for the preparation and review of regulatory submissions consistent within US… more
- Teva Pharmaceuticals (West Chester, PA)
- Manager , Regulatory Affairs Date: May 5, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: 61795 **Who we ... spend your day** Teva Pharmaceuticals USA Inc. seeks a Regulatory Affairs Manager in our West Chester,...the organization and archive communication per standard practice. + Review guidance's and regulations for regions within scope of… more
- Lilly (Philadelphia, PA)
- …to make life better for people around the world. Responsibilities: The Associate / Manager , CMC Regulatory and IMP Manufacturing Operations is a hybrid role ... Development supporting the two functional areas. The Associate / Manager is responsible for CMC regulatory operations,... Information Management (RIM) system) + Manage the preparation, review , and submission of global CMC regulatory … more
- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work on-site at ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - APAC** position will...strategies on complex issues + Work closely with in-country regulatory representatives, compile, prepare, and review medical… more
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