Senior Regulatory Affairs Manager
Virtual Vocations Inc
To support the pharmaceutical product lifecycle, the full-time Senior Regulatory Affairs Manager will provide regulatory guidance on labeling and advertising, manage the creation and approval of labeling documents, and ensure compliance with promotional regulations while working remotely. Key responsibilities Provide regulatory guidance on labeling, ad promo, and artwork-related issues to internal teams and external clients Manage the creation, review, and approval of labeling documents, including prescribing information and packaging Review and approve promotional materials, ensuring alignment with regulatory guidelines and corporate standards Required qualifications Bachelor's degree in a scientific discipline or related field Minimum of 10 years of experience in regulatory affairs with a focus on labeling, ad promo, and artwork in the pharmaceutical or biotechnology industry
- The Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring that approval is maintained throughout... ...AD will typically collaborate, influence and negotiate with senior Nonclinical / Clinical leaders on product strategies and actions...Senior
- Responsibilities: Support the Senior Director in developing and executing regional regulatory strategies for QOL initiatives within... ...Director. Contribute to managing regulatory risks and opportunities... ...of experience in regulatory affairs within the pharmaceutical or biotech...Senior
- ...related to product under development. Preparation, submission, and monitoring of PLAIR activities, prior to new product launch Manage regulatory correspondence mainly to CDER, FDA, User fee staff, drug listing and Board of Pharmacies for state licensing submissions....SeniorLocal area
$154.4k - $231.6k
..., and impact.A Day in the LifeThis position sits within the Regulatory Affairs Data and Product Release group in the Medtronic Clinical & Regulatory... ...direction and people leadership, coaching and developing managers and teams to deliver timely, accurate, and compliant product...SeniorFull timeH1bWork at officeLocal areaImmediate startFlexible hours- ...Senior Regulatory Affairs Manager At Argenta, we're more than a company — we're a global team, dedicated to healthier animals. We believe that when their lives are made better, we're all the better for it. Founded in 2006, we support companies big and small to develop...SeniorContract workRemote workWork from homeFlexible hoursShift work
- ...Senior Regulatory Project Manager ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future...SeniorFlexible hours
- ...Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development and lifecycle... ...or train staff; may have direct line management responsibility. Manage project activities... ...professional growth in global regulatory affairs, including communication of evolving/...SeniorWork at officeLocal areaRemote workWorldwide
- ...and cosmetics to introduce creative products and services based on our customers' needs. About the role: The Senior Regulatory Affairs Manager ensures regulatory compliance of The client / LG H&H US cosmetic, OTC, dietary supplement, and device products from...SeniorFixed term contractLocal areaFlexible hours3 days per week
$154.4k - $231.6k
...A Day in the Life This position sits within the Regulatory Affairs Data and Product Release group in the Medtronic Clinical & Regulatory... ...strategic direction and people leadership, coaching and developing managers and teams to deliver timely, accurate, and compliant product...SeniorH1bWork at officeLocal areaFlexible hours$154.4k - $231.6k
...impact. A Day in the Life This position sits within the Regulatory Affairs Data and Product Release group in the Medtronic Clinical &... ...strategic direction and people leadership, coaching and developing managers and teams to deliver timely, accurate, and compliant product...SeniorH1bWork at officeLocal areaImmediate startFlexible hours- ...A medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class II medical devices. Responsibilities include managing FDA submissions, ensuring regulatory compliance throughout product development, and collaborating...Senior
- Initial Therapeutics, Inc. is seeking a Manager of Regulatory Affairs to oversee regulatory document preparation and ensure compliance with FDA regulations. The role involves working closely with cross-functional teams, preparing submissions, and advising management on...Senior
- ...CONMED Corporation is seeking a Manager, Regulatory Affairs to lead regulatory strategy and execution for medical devices in domestic and international markets. This on-site role in Denver, CO focuses on submissions, agency interactions, labeling review, and lifecycle...Senior
- Direct message the job poster from GForce Life Sciences Senior Regulatory Affairs Manager 12-month Contract, Remote Must be able to work on a W2 Requirements Regulatory Strategy Development Lead the development, integration, execution, and maintenance of the global nonclinical...SeniorContract workRemote work
$160k - $200k
...facilities strategically located in key regions throughout the world.Senior Manager of U.S. Export ComplianceThe Senior Manager of U.S. Export... ....Determine and implement new procedures as needed to address regulatory changes and emerging export compliance risks.Develop and...SeniorWork experience placementRemote workWork from homeFlexible hours- ...requirements in partnership with our existing outsourced vendors and (2) management of ongoing key ESG partnerships - Frontier (through Watershed;... ...a strong emphasis on accurate data interpretation and timely regulatory submissions.Key ResponsibilitiesThis role will need to...SeniorWork at office
$130.7k - $261.3k
...place to work for diversity, working mothers, female executives, and scientists.The Opportunity We are recruiting for a Senior Regulatory Affairs Manager to join our Digital Solutions team on-site in Sylmar, CA or Santa Clara, CA. In this role, you will combine knowledge...SeniorWork experience placementWorldwideShift work$146k - $215k
...Global Aerospace group is seeking a Sr. Manager of Compliance, Global Repair Stations. This... ...who is passionate about aviation regulatory compliance, team leadership, people development... ...integrated global enterprise. The Senior Manager of Compliance for Aerospace Global...SeniorPermanent employmentLocal areaRemote workRelocation package$146k - $215k
...Global Aerospace group is seeking a Sr. Manager of Compliance, Global Repair Stations. This... ...who is passionate about aviation regulatory compliance, team leadership, people development... ...one integrated global enterprise. The Senior Manager of Compliance for Aerospace...SeniorPermanent employmentLocal areaRemote workRelocation package- Job Description: The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory submissions, including 510(k) and submissions. This individual will ensure compliance with all applicable regulations in the preparation of the submissions...Senior
- ...Senior Vice President, Head of Compliance About the Company Accomplished provider of personal loans & related services... ...Risk Officer, and oversee all aspects of compliance, including managing regulatory exams, audits, and reporting. The role also involves...Senior
$63.79k - $80.01k
...documentation standards to strengthen enterprise consistency. - Serve as senior liaison with the Department of Revenue and other agencies on... ...data-sharing matters. - Partner strategically with Account Management, Legal, Audit, and external stakeholders to resolve compliance...Senior16 hoursFull timeWork experience placementWork at office- Job Description: This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization... ...will contribute: With some supervision, plans, executes and manages regulatory submissions according to the regulatory strategy...Senior
- ...clients seeking world-class professional resources.Job DescriptionUS Regulatory Advertising and Promotion (US Reg AD/Promo) is responsible for... ...according to EEO guidelines.SummaryType: ContractFunction: ManagementExperience level: Mid-Senior LevelIndustry: PharmaceuticalsSeniorFor contractors
$145k - $215k
...inclusivity, so that our people are valued, seen, and heard.How you’ll make an impact:Kymera Therapeutics is seeking a Senior Manager, Regulatory Affairs to serve as a key regulatory contributor and emerging strategic leader across multiple drug development programs....Senior- Responsibilities: The Regulatory Manager (RM) provides regulatory strategy and development guidance... ...as representative of Global Regulatory Affairs at project team meetings with both... ...Regulatory experience required for the Senior Manager Regulatory level. Candidates must...SeniorFlexible hoursNight shift
$280k - $310k
...get it done, and have fun, seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will provide... ..., and effectively oversees change controlsBuilds and manages relationships through active partnering with key...SeniorLocal area- ...Summary Position Summary: The Senior Vice President, Chief Compliance... ...the Bank’s enterprise compliance management system and provides strategic oversight of regulatory compliance, CRA, fair lending,... ..., risk management, regulatory affairs, legal, or related financial services...SeniorOngoing contractFull timeWork at office
$134.2k - $202.2k
...Please do not share outside of the organization.Your Role:The Senior Manager Regulatory CMC (RCMC) is responsible and accountable for driving all... ...submissions worldwide, and serves as the Regulatory Affairs CMC contact point and acts as the liaison with the GHO and...SeniorLocal areaImmediate startWorldwide$137k - $215.27k
...therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices... ...will contribute:With some supervision, plans, executes and manages regulatory submissions according to the regulatory strategy...SeniorMinimum wageTemporary workLocal areaRemote workWorldwide
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