Director, Regulatory Affairs Advisor & Liaison Discover Financial ServicesDirector, Regulatory Affairs Advisor & LiaisonRichmond, VA$230,400–$263,000 / yearSynthesize trends within the external landscape and local regulatory engagements and drive internal awareness of focus areas and potential sensitivities to minimize regulatory risk and ensure the company is exceeding expectations set forth by law, regulation, and agency guidance. We provide key advisory consulting to senior management with respect to supervision and evolving regulatory issues, while also supporting policy development and risk management thought leadership.
Associate Director, Global Oncology Medical Affairs, Early Pipeline Daiichi Sankyo, Inc.Associate Director, Global Oncology Medical Affairs, Early PipelineBasking Ridge, NJ$171,120–$256,680 / yearFull timeThe Associate Director Global Medical Affairs Oncology (GMA), under the direction of the Senior Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical strategies and for leading select medical affairs projects within a specific compound or indication. Provides medical leadership in interactions with key external stakeholders and lead Scientific Engagement activities such as planning advisory boards, managing individual stakeholder interactions and peer to peer discussions, congress engagement activities, and collation of insights for select indications related to the compound.
Sr. Regulatory Affairs Specialist JouléSr. Regulatory Affairs SpecialistMountain View, CA$55–$60 / hourSystem One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. Provide regulatory guidance to product teams, develop strategies for the U.S. and Canadian markets, and influence global regulatory strategies.
Regulatory Affairs Specialist IV JouléRegulatory Affairs Specialist IVMountain View, CA$60 / hourMinimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs master degree; e.g., Masters in Regulatory Science). • Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation and regulatory submissions.
NewDirector, Omnichannel - Global Oncology Medical Affairs Daiichi Sankyo, Inc.Director, Omnichannel - Global Oncology Medical AffairsBasking Ridge, NJ$189,600–$284,400 / yearFull timeDemonstrated experience in content management strategy including digitalizing and modularizing medical content; Proven leadership skills in a cross-functional global team environment; Experience in managing cross-functional teams, collaborating with diverse stakeholders and with the ability to influence without authority; Strong knowledge of industry best practices; Strong understanding of regulatory requirements and compliance considerations in the pharmaceutical industry; Excellent leadership and communication skills, with the ability to partner and work with teams across regions and functions required. Cross-team Collaboration: Work with a cross-functional medical affairs team including Franchise and GMAT leads, Region (Medical, Omnichannel, and Analytics) leads, Affiliate Medical Directors, Content Team, Scientific Engagement Team, Analytics and Data Teams to enable medical engagement strategy (i.e. medical journeys with associated outcomes) and enable capability pull-through.
NewMedical Affairs/Safety - Associate Director, Patient Advocacy and Engagement - Contract TalentBurst, Inc.Medical Affairs/Safety - Associate Director, Patient Advocacy and Engagement - ContractCambridge, MA$60–$83.74 / hourThe Associate Director, Patient Advocacy and Engagement, Rare and Pipeline will play a critical role in driving patient-centric strategies and strengthening relationships with patient advocacy organizations primarily in US. Develop initiatives to enhance disease awareness and improve time to diagnosis, as well as educate the patient community so that they are empowered to actively engage with their healthcare provider in the management of their disease.
NewRegulatory Affairs Manager I_CO - Contract TalentBurst, Inc.Regulatory Affairs Manager I_CO - ContractIndianapolis, IN$50–$53 / hourThe efficiency and the success of the Regulatory activities and strategies are maintained by clear agreements with other functions, stakeholders and external partners (authorities, companies, NBs etc). Contributes to or leads projects with an understanding of how business functions, systems, processes, and data management are connected and essential to achieving digitalization and strategic goals.
NewMedical Affairs Scientific Communications Director - Movement Disorders LundbeckMedical Affairs Scientific Communications Director - Movement DisordersDeerfield, ILThis individual will partner closely with HEOR, Commercial, Customer insights & analytics, Patient advocacy, Clinical Development, Compliance, Legal, Medical Affairs Operations, and Medical Affairs teams and external experts to ensure scientific materials are accurate, balanced, compliant, and aligned with medical objectives while serving as a scientific communications expert across the organization. Oversee development of all US medical materials, medical slide decks, FAQs, scientific response documents, congress assets, field medical materials, training content, data visualizations, digital scientific content, and other non-promotional medical resources ensuring scientific accuracy, regulatory compliance, and strategic alignment.
NewRegulatory Specialist # 26-22388 US Tech Solutions, Inc.Regulatory Specialist # 26-22388Reynoldsburg, OHResponsibilities Individual contributor Responsible for providing day to day global regulatory support & execution for the Regulatory Affairs department to aid in the successful launch and lifecycle of compliant products from ingredient review to label assessment to government product submissions, documentation, and related dossiers to ensure accuracy and completeness for global product launches. US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions.
NewSenior Associate, Digital Trust & Safety KPMGSenior Associate, Digital Trust & SafetyWashington, DCIf you're looking for a firm with a strong team connection where you can be your whole self, have an impact, advance your skills, deepen your experiences, and have the flexibility and access to constantly find new areas of inspiration and expand your capabilities, then consider a career in Advisory. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness, and safeguard business operations and company reputation.
Associate Director, Clinical Trial Disclosure & Transparency CSLAssociate Director, Clinical Trial Disclosure & TransparencyKing of Prussia, PAThis role guides global strategy, drives process excellence, and oversees the delivery of clinical trial disclosure activities including registration, results disclosure and layperson summaries while providing support for transparency activities including anonymization and redaction of commercially confidential information (CCI) as required for business continuity and operational needs. The Associate Director Clinical Trial Disclosure and Transparency is a global subject matter expert responsible for ensuring timely, accurate, and compliant clinical trial disclosures across all regions and study types (interventional and observational).
NewRecords & Information Specialist ECLARORecords & Information SpecialistWhite Plains, NYPosition Overview: The Records & Information Specialist role supports the Corporate Records team by reviewing, preparing, digitizing, and classifying hardcopy documents for inclusion in the organization's Records Management System. Familiarity working with a Records Retention Schedule by associating documents with their Record Series Titles, retention periods, regulations, and RM File Numbers.
NewMedical Reviewer/Safety Reviewer - # 26-22286 US Tech Solutions, Inc.Medical Reviewer/Safety Reviewer - # 26-22286VO, ILJob Description: Provides timely assessment of reported clinical trial data and participates in applicable safety surveillance activities for assigned studies including review of labs, vital signs, cardiac, medications, medical history, and can communicate with Study Lead any findings. May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification.
Regulatory Affairs Specialist Regulatory Affairs Specialist LancesoftRegulatory Affairs Specialist Regulatory Affairs SpecialistTrumbull, CT$30Skills —strong communication skills, ability to manage projects with cross functional teams, proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), SAP experience helpful. Manage workload, priority and performance of regulatory staff, in addition to providing development opportunities to build capability.
Associate Regulatory Affairs Professional to Senior Regulatory Affairs Professional Halliburton CoAssociate Regulatory Affairs Professional to Senior Regulatory Affairs ProfessionalHouston, TXCollaborates with chemical stewardship team members to evaluate and minimize risk and to drive compliance of existing products lines, changes, and innovation projects in support of chemical stewardship and regional objectives. Provides technical support to product lines to commercialize new and amended registered chemical products, minimize time to market, and ensure continued compliance on the market.
Sr. Regulatory Affairs Associate Avion PharmaceuticalsSr. Regulatory Affairs AssociateAlpharetta, GeorgiaThe Senior Regulatory Affairs Associate is responsible for preparing submissions in eCTD format, actively participating in client meetings, interacting with the various governmental agencies when needed, and assessing change control for regulatory impact. Proactively work with clients to ensure a successful working relationship by providing information, documentation, and regulatory advice in a timely manner.
NewRegulatory Affairs Associate Generis Tek Inc.Regulatory Affairs AssociateSouth Portland, ME$20–$22 / hourPost market: Update and maintain global product listings, facility registrations, licenses/approvals, and annual registrations; Assist in the preparation of routine reports and regulatory agency communications; Assist in the preparation of post market reports and submissions; Update and maintain paper/electronic document archival systems; Prepare legal documents for import/export, registrations, tenders/bids or other purposes; Serves as regulatory liaison throughout product lifecycle. Strategic Planning: Assist in SOP development, review and initiation; Stay abreast of regulatory procedures and changes in regulatory climate and update department; Investigate regulatory history of similar products to assess approval implications; Conduct research on submission requirements and options; Assist in monitoring and reporting project timelines; Respond to regulatory information requests; and Monitor and utilize tracking and control systems.
Regulatory Affairs Associate Immuno-Mycologics IncRegulatory Affairs AssociateNorman, OKRequired: Bachelor's degree in related discipline or combination of other education/job related experience; 2+ years of Regulatory Affairs job experience required for Specialist categorization. The Regulatory Affairs Associate/Specialist is primarily responsible for preparing IVD regulatory documents for submission to various regulatory agencies, both domestic and international.
Regulatory Affairs Associate/Senior Associate Azurity PharmaceuticalsRegulatory Affairs Associate/Senior AssociateRaleigh, NCAs an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The Regulatory Affairs Associate/Senior Associate will report to the Associate Director, Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Technical Operation, Quality Assurance, Clinical Development, Medical Affairs.
Regulatory Affairs Associate/Senior Associate Azurity Pharmaceuticals IncRegulatory Affairs Associate/Senior AssociateRaleigh, NCAs an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The Regulatory Affairs Associate/Senior Associate will report to the Associate Director, Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Technical Operation, Quality Assurance, Clinical Development, Medical Affairs.