- 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
- US Bank (St. Paul, MN)
- …you excel at-all from Day One. **Job Description** US Bank is hiring a **BL Regulatory Review Representative** to support our _Fiduciary Review Group (FRG) ... ensure flagged items/issues are resolved. As an individual contributor on the Fiduciary Review Group (FRG) Administrative Review Team, reviewer will: + Complete… more
- BlackRock (Boston, MA)
- **About this role** **Associate, Global Product Solutions ETF Regulatory Marketing Review ** **Location: Boston** **About this role** Elevate your career by ... are seeking an Associate to join the iShares Communications Review team. This team is tasked with the ...and compliance groups and FINRA staff to help ensure regulatory compliance of marketing and sales collateral, digital content,… 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, and ... day-to-day may include: + Supporting audit teams that are selected for regulatory inspection + Communicating and interaction with the firm's regulators + Conducting… more
- Gilead Sciences, Inc. (Foster City, CA)
- …6+ years' relevant experience. + For external candidates, 1+ years' experience in regulatory review of promotions for prescription drugs or other biologic ... their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within… more
- TD Bank (Mount Laurel, NJ)
- …and monitoring team travel, education costs, and other expenses + Leads team to review regulatory trends or themes noted during bank examinations and ongoing ... at TD Bank follow the defined RPM process. + Leads discussions of Regulatory Review Council related to tasked exams and participate in various Senior and… more
- Takeda Pharmaceuticals (Boston, MA)
- … Advisor and function as the "R" in the core Medical, Legal, and Regulatory review functions within the Commercial Material Review Process (CMRP). ... to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is… more
- Abbott (Santa Clara, CA)
- …Monitor impact of changing regulations on submission strategies. + Monitor applications under regulatory review . + Monitor and submit applicable reports to ... post-marketing approval requirements. + Assess external communications relative to regulations. + Review regulatory aspects of contracts. + Assist with label… more
- Kelly Services (Bridgewater, NJ)
- …support launch strategies and marketing initiatives. **Key Responsibilities:** + Provide regulatory review and approval of advertising, promotional, and training ... impact and mitigate risk. + Serve as a member of the Promotional Review Committee (PRC), providing expert guidance on regulatory implications for proposed… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …+ An advanced degree and at least 10 years of experience in regulatory review of promotional materials for prescription drug and/or biologic products ... Affairs. **Responsibilities:** + Lead, develop, and mentor a team of regulatory advertising and promotion professionals, including a Review team, and… more
- Edwards Lifesciences (Irvine, CA)
- …+ Close collaboration with various cross functional teams including Medical, Legal and Regulatory review of Advertising and Promotion, Grant Reviews and Program, ... needs and interests of the patients we serve. The Senior Director, Corporate & Regulatory Counsel role is a blend of subject matter legal expert and strong business… more
- Abbott (Plymouth, MN)
- …submission strategies and update internal stakeholders. Monitor applications under regulatory review . Communicate application progress to internal stakeholders. ... of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submission to authorities. + Evaluate… more
- Abbott (Sylmar, CA)
- …submission strategies and update internal stakeholders + Monitor applications under regulatory review + Communicate application progress to internal stakeholders ... and clinical documentation for submission filing + Compile, prepare, review and submit regulatory submission to authorities...filing + Compile, prepare, review and submit regulatory submission to authorities + Monitor impact of changing… more
- Takeda Pharmaceuticals (Boston, MA)
- …Brings any critical regulatory topics for assigned programs to the regulatory review forum for discussion. + Ensures accurate, up-to-date reporting of ... highlight any major dsicrepancies for assigned programs. + May lead regulatory review in due diligence for licensing opportunities. DIMENSIONS AND ASPECTS… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …teams of the impact on the business or development programs. + Responsible for regulatory review and perspective on BD opportunities This role might be for ... key leadership role, you will build and oversee Global Regulatory Science and Regulatory CMC strategic framework...review to a final decision by health care regulatory authorities, specifically including FDA and EMA. + Identifies… more
- Abbott (Maple Grove, MN)
- …Change Assessment + International Product Registration support + Ad and Promotional Material - Regulatory Review + EU and US medical device compliance + Project ... **The Opportunity** We are looking for our next **Senior Regulatory Quality Specialist** to join our team on-site out...change order activities + Create supplemental training materials + Review and follow document quality system structure + Lead… more
- Abbott (Maple Grove, MN)
- …Assessment + International Product Registration support + Ad and Promotional Material - Regulatory Review + Project management skills - organize and host ... diabetes from routine fingersticks. **The Opportunity** We are looking for our next ** Regulatory Operations Compliance Manager** to join our team on-site out of our… more
- Envista Holdings Corporation (Brea, CA)
- …registrations and device/drug listings (as required). + Responsible for assisting in regulatory review of product claims and literature. + Prepares monthly ... is responsible for assembling CE Technical files and final review of deliverables for MDR regulatory compliance...and final review of deliverables for MDR regulatory compliance with the goal of achieving notified body… more
- ERP International (Laurel, MD)
- …AL and San Antonio, TX - plus project locations nationwide. **Responsibilities** + ** Regulatory Review and Impact Analysis:** + Analyze CMS laws, regulations, ... Alignment Support:** + Collaborate with technical teams to extract, review , and validate regulatory data from the...technical teams to extract, review , and validate regulatory data from the Federal Register. + Support AI/ML-related… more
- BeOne Medicines (San Mateo, CA)
- …complaints arise during product lifecycle for the assigned project. + Provide CMC regulatory review for clinical protocols and investigator brochures, etc. for ... **_General Description:_** BeOne is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent… more
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