NewSenior Director, Medical Affairs CellectisSenior Director, Medical AffairsNew York, NY$175,000–$225,000 / yearReporting to the Chief Medical Officer, this leader will elevate Cellectis’ scientific presence, support pipeline advancement, and ensure medical excellence in evidence generation, scientific communications, and external engagement. Cellectis is seeking a highly experienced Senior Director, Medical Affairs to help shape and operationalize the company’s medical affairs strategy across its clinical‑stage portfolio.
NewAssociate Director, State Government Affairs - Remote Agios PharmaceuticalsAssociate Director, State Government Affairs - RemoteNew York, NYRemote$153,541–$230,312 / yearThe current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.
NewDirector, Global Affairs Take-Two Interactive Software, Inc.Director, Global AffairsNew York, NY$163,400–$241,820 / yearAs Director, Global Affairs (Americas), you will take a leading role in Take-Two’s public policy activities across North and South America, developing and implementing legislative and regulatory advocacy strategies on a broad range of issues in support of Take-Two’s business. You will monitor legislative and regulatory trends across North and South America and develop strategies on a broad range of policy issues impacting the video game industry and Take-Two’s products and services, such as online safety, age assurance, consumer protection, privacy, AI, and more.
NewSenior Manager, Medical Affairs Operations - Remote Agios PharmaceuticalsSenior Manager, Medical Affairs Operations - RemoteNew York, NYRemote$131,035–$196,553 / yearManage the execution of Agios’ patient advocacy conference plans for PK deficiency, thalassemia, and sickle cell disease; participate in cross-functional planning meetings; obtain compliance approval for related materials; and attend virtual and in-person conferences, when needed. Provide operational and project management support to the US patient advocacy team, ensuring smooth day-to-day coordination across priorities, stakeholders, and deliverables, and flex to support various other functions within Medical Affairs as needs arise.
NewDirector, Regulatory Strategy (Pediatrics) - Remote Agios PharmaceuticalsDirector, Regulatory Strategy (Pediatrics) - RemoteAnywhere, NYRemote$183,549–$275,324 / yearThe current base salary range for this position is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This individual will lead cross-functional teams in preparing and overseeing development of compliant, high quality, nonclinical and clinical global regulatory submissions to support development, registration, or life cycle management activities.
NewDirector, Cybersecurity Policy and Diplomacy Team (CPD) MicrosoftDirector, Cybersecurity Policy and Diplomacy Team (CPD)New York, NY$132,200–$258,000 / yearBachelors Degree in Public Policy, Public Administration, Political Science, Business Administration, Technology, Law, Liberal Arts, Engineering, or related field AND 6+ years work experience in government affairs, corporate affairs, public policy, government, or related areaOR equivalent experience. There is a different range applicable to specific work locations, within the San Francisco Bay area and New York City metropolitan area, and the base pay range for this role in those locations is USD $165,800 - $278,900 per year.
NewAssociate Director, Patient Advocacy – Patient Community Ambassador (Mid-Atlantic or South) Agios PharmaceuticalsAssociate Director, Patient Advocacy – Patient Community Ambassador (Mid-Atlantic or South)Anywhere, NY$153,541–$230,312 / yearThe current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Identify opportunities to build and strengthen relationships with local patients, patient support groups, advocacy organizations, and multicultural centers to ensure we better understand the needs of the patient communities.
NewAssociate Director, Scientific Communications & Publications - Remote Agios PharmaceuticalsAssociate Director, Scientific Communications & Publications - RemoteNew York, NYRemote$153,000–$230,000 / yearOperating at the intersection of strategy and execution, this role partners closely with cross-functional colleagues and external experts to deliver high‑impact publications and scientific communications that advance both patient care and scientific dialogue. The current base salary range for this position is expected to be between $153,000 and $230,000 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
NewAssociate Director/ Director, Patient Marketing - Remote Agios PharmaceuticalsAssociate Director/ Director, Patient Marketing - RemoteAnywhere, NYRemote$183,549–$275,324 / yearThe current base salary range for this position at the Associate Director level is expected to be between $153,541 and $230,312 annualized and the current base salary range for this position at the Director level is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. The Associate Director/Director, Patient Marketing will focus on developing and executing the patient strategy in preparation for the future launch of mitapivat, currently in development for sickle cell disease, a vastly underserved community.
NewMedical Director, Sickle Cell Disease, Clinical Development Agios PharmaceuticalsMedical Director, Sickle Cell Disease, Clinical DevelopmentAnywhere, NY$221,600–$369,333 / yearThe current base salary range for this position is expected to be between $221,600 and $369,333 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Follow important developments and relevant trends in scientific literature and develop/maintain contracts with external experts to support understanding of the candidate drug effects and to gain strategic insights to the further development and placement of study and overall program.
Director / Senior Director of Regulatory Affairs PathosDirector / Senior Director of Regulatory AffairsNew YorkDirect IND lifecycle management experience: you have owned INDs from filing through amendment cycles, authored DSURs, prepared IB updates, and built FDA meeting packages as the primary author. That means authoring DSURs, preparing IB updates and IND amendments, building FDA meeting packages, managing ClinicalTrials.gov listings, and overseeing eCTD publishing.
Executive Director, Regulatory Affairs - Global Regulatory Leader Summit Therapeutics IncExecutive Director, Regulatory Affairs - Global Regulatory LeaderNY$231,000–$285,000 / yearOverview of Role: The Executive Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various studies as well as providing regulatory leadership for planning and execution of subsequent global marketing applications (BLA/MAA) for product(s) in the oncology therapeutic area. HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
Director of Individual Insurance Compliance & Regulatory Affairs Alera Group IncDirector of Individual Insurance Compliance & Regulatory AffairsNY$120,000–$165,000 / yearp>Reporting directly to the Chief Legal Officer with a dotted-line partnership to the SVP of Strategy & Operations, this role will collaborate across Legal, Operations, Marketing, IT, Carrier Relations, and agency leadership to drive consistency, accountability, and audit readiness throughout the organization. This senior leadership role is responsible for building scalable, defensible compliance frameworks that support growth while ensuring regulatory excellence across Medicare, ACA, and ancillary insurance products.
Director, Commercial Regulatory Affairs, Labeling, Advertising, and Promotion Syndax PharmaceuticalsDirector, Commercial Regulatory Affairs, Labeling, Advertising, and PromotionNew YorkRemoteConducts precedent searches, analyzes relevant analogs or competitor labeling, labeling guidance and trends; and develops labeling language for inclusion to assigned product labels (TLP, CCDS, USPI, when applicable EU SmPC,) to ensure consistency with the overall product strategy, product claims and information in the CCDS. Leads Labeling cross-functional working group (LWG) and interacts with cross-functional senior leadership to resolve complex issues, including leading and contributing to cross-functional initiatives by providing expertise in labeling best practices.
Associate Director, Regulatory Affairs Recursion Pharmaceuticals IncAssociate Director, Regulatory AffairsNYRemote$176,400–$207,500 / yearli>Create and follow procedures for regulatory execution and implementation of regulatory strategies while actively supporting program leads via the Clinical Study Teams (CSTs) to deliver on business objectives for assigned products/programs (e.g. Powered by proprietary multimodal data, purpose-built AI models, and bilingual teams fluent in both science and AI, the Recursion OS is designed to translate complex science into medicines that matter faster, better, and at scale for patients who are waiting.
Medical Director, Clinical Regulatory Affairs Oscar Health IncMedical Director, Clinical Regulatory AffairsNew York, NYRemote$264,000–$346,000 / yearWork Location: You must reside in one of the following states: Arizona, California, Colorado, Connecticut, D.C., Florida, Georgia, Illinois, Iowa, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New Mexico, New York City, North Carolina, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, or Utah. You will advise senior leadership and work closely with teams across the organization to ensure clinical operations align with policy and regulatory intent.
Director, Commercial Regulatory Affairs, Labeling, Advertising, and Promotion Syndax Pharmaceuticals IncDirector, Commercial Regulatory Affairs, Labeling, Advertising, and PromotionNYRemote$225,000–$250,000 / yearli>Conducts precedent searches, analyzes relevant analogs or competitor labeling, labeling guidance and trends; and develops labeling language for inclusion to assigned product labels (TLP, CCDS, USPI, when applicable EU SmPC,) to ensure consistency with the overall product strategy, product claims and information in the CCDS. Leads Labeling cross-functional working group (LWG) and interacts with cross-functional senior leadership to resolve complex issues, including leading and contributing to cross-functional initiatives by providing expertise in labeling best practices.
Senior Director, Regulatory Affairs Strategy Immunovant IncSenior Director, Regulatory Affairs StrategyNew York, NY$270,000–$290,000 / yearThe Senior Director will provide deep regulatory expertise, lead health authority interactions, mentor regulatory leaders, and partner closely with cross-functional and Regulatory leadership to ensure consistent, high-quality regulatory strategies that support corporate objectives. Provide direct or matrix leadership to Regulatory Strategy personnel (e.g., Managers, Associate Directors, Directors), including coaching, mentoring, and development of future regulatory leaders.
Director, Regulatory Affairs Nektar TherapeuticsDirector, Regulatory AffairsNY$240,000–$275,000 / yearThis role oversees end-to-end planning and delivery of global clinical submissions, leads the creation and release of core regulatory dossiers, drives country-level customization strategies, and ensures high-quality responses to regulatory RFIs to support timely trial startup and advancement. Nektar currently anticipates the base salary for the Senior Specialist, Clinical Regulatory Affairs to range from $240,000 to $275,000 for candidates in the Bay Area and will depend, in part, on successful candidate''s location and qualifications for the role, including education and experience.
Associate Director, CMC Regulatory Affairs Recursion Pharmaceuticals IncAssociate Director, CMC Regulatory AffairsNYRemote$176,400–$228,250 / yearPowered by proprietary multimodal data, purpose-built AI models, and bilingual teams fluent in both science and AI, the Recursion OS is designed to translate complex science into medicines that matter - faster, better, and at scale - for patients who are waiting. Recursion is advancing a portfolio of differentiated investigational medicines across its wholly owned and partnered pipeline in oncology, rare disease, neuroscience, immunology, and other therapeutic areas with significant unmet need.
Associate Director, CMC Regulatory Affairs (Hematology/Oncology) Regeneron Pharmaceuticals IncAssociate Director, CMC Regulatory Affairs (Hematology/Oncology)NYRemote$157,200–$256,600 / yearPerform final review and approval of the compliance activities of the portfolios to confirm regulatory impact and associated submission requirements for clinical and commercial regulatory filings in accordance with country-specific regulatory guidance documents; • Mentor colleagues in difficult compliance assessment discussions with SMEs or Senior Management; find opportunities for improvement of processes for compliance tasks. • Critically review and provide meaningful and strategic input on regulatory filing documents (e.g., INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements) to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics.
Associate Director/Director, Regulatory Affairs Axsome TherapeuticsAssociate Director/Director, Regulatory AffairsNew York City, NYRemote$160,000–$215,000 / yearFor more information, please visit us at www.axsome.com and follow us on LinkedIn and X. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States.
Senior Director, Clinical Regulatory Affairs Umoja BioPharma IncSenior Director, Clinical Regulatory AffairsNY$253,000–$312,500 / yearThis role will develop and implement regulatory strategies leading to successful registration and life-cycle management of unique and technologically complex products serving patients with cancer and other unmet medical needs. • Provide regulatory advice and guidance in the context of available and expected scientific data, regulatory guidance, and precedent to project teams to support decision making and program advancement.
Director, Regulatory Affairs Bausch & Lomb IncDirector, Regulatory Affairs$165,000–$220,000 / yearThe Director partners cross‑functionally with Clinical, Nonclinical, CMC, Quality, Safety, and Regulatory Operations to develop global regulatory strategies, lead health authority interactions, ensure high‑quality submissions, and manage regulatory risk across the product lifecycle. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe.
NewDirector, Regulatory Affairs Strategy - Genetics Medicine Regeneron Pharmaceuticals IncDirector, Regulatory Affairs Strategy - Genetics MedicineNY$205,000–$341,600 / yearThe Director will develop and maintain regulatory strategy at the study, indication, and program level, lead interactions with global health authorities, and serve as a key cross-functional partner and subject matter expert. Working with cross-functional project teams to resolve complex regulatory issues, utilizing deep expertise in global regulations and guidances to strategically plan and communicate requirements.
Associate Director, Regulatory Affairs BeOne Medicines AGAssociate Director, Regulatory AffairsNY$146,700–$196,700 / yearli>Provides strategic and operational regulatory direction on assigned projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval, risk assessments, critical issue management and advice on health authority interactions. Excellent verbal and written skills; able to analyze, define, and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders.
Associate Director, Regulatory Affairs Nuvation Bio, Inc.Associate Director, Regulatory AffairsRemote - Any State US, NYRemote$190,000–$200,000 / yearWe are looking for an experienced hands-on Regulatory Affairs professional to contribute to the development strategy and lead in the planning, preparation, submission and maintenance of regulatory submissions for Nuvation products. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.
Regulatory Affairs Director - Hybrid (Bronx Office) CareSourceRegulatory Affairs Director - Hybrid (Bronx Office)NY$135,600–$237,400 / yearJob Summary: The Regulatory Affairs Director is responsible for leading activities of the Regulatory Affairs Department, including contracts, compliance, surveys, audits, investigations, reporting, plan development and renewal, credentialing, Fraud, Waste & Abuse Special Investigations, provider network and relations, regulatory updates and compliance matters. CareSource takes into consideration a combination of a candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required for the role, and other external and internal data when establishing a salary level.
Regulatory Affairs Director - Hybrid CareSourceRegulatory Affairs Director - HybridBronx, NY$135,600–$237,400 / yearJob Summary: The Regulatory Affairs Director is responsible for leading activities of the Regulatory Affairs Department, including contracts, compliance, surveys, audits, investigations, reporting, plan development and renewal, credentialing, Fraud, Waste & Abuse Special Investigations, provider network and relations, regulatory updates and compliance matters. 2 Days work from home; 3 Days work in Bronx office each week Compensation Range: $135,600.00 - $237,400.00 CareSource takes into consideration a combination of a candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required for the role, and other external and internal data when establishing a salary level.
Director - Compliance Coordination and Regulatory Affairs Credit Agricole SADirector - Compliance Coordination and Regulatory AffairsNY$190,000–$240,000 / yearThe Director- Compliance Coordination and Regulatory Affairs is a senior role within the Compliance Team responsible for the following functions:Regulatory Engagement & Examination ManagementServe as Compliance primary point of contact for U.S. regulatory agencies during examinations, inquiries, and ongoing supervisory activities;Coordinate and manage end-to-end regulatory examinations, including preparation, document production, regulatory meetings, and remediation efforts;Develop and maintain examination response protocols and methodology;Track and manage regulatory requests to ensure timely, accurate, and complete responses;Review and challenge regulatory deliverables;Support regulatory inquiries and examinations in the Americas and across business lines as needed;Internal Audit CoordinationPartner with Internal Audit to coordinate compliance-related audit reviews;Manage audit response processes, including deliverables validation and review;Strategic Project LeadershipLead and contribute to high-priority compliance projects and department-wide initiatives;Collaborate with cross-functional teams to implement compliance program enhancements;Drive process improvements and automation opportunities within the compliance function;Stakeholder ManagementBuild and maintain productive relationships with regulatory agencies;Partner with other divisions (business lines/support functions) on compliance matters;Provide regular updates to senior leadership on regulatory developments and examination status. This team has a number of different functions, but its primary functions are the management of interactions with US Regulators, management of compliance projects, tracking and reporting of issues, quality assurance, regulatory watch and support to regulatory changes, compliance communication, and regulatory coordination.
Director, Global Regulatory Affairs Protara Therapeutics IncDirector, Global Regulatory AffairsNY$228,000–$233,000 / yearThe Director, Global Regulatory Affairs will provide leadership on ex-US regulatory activities for Protara's product portfolio, and responsibility will focus on clinical study applications and provide regulatory leadership on the project teams in this area. The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs.
Senior Director Regulatory Affairs, CMC BeOne Medicines AGSenior Director Regulatory Affairs, CMCNY$204,500–$274,500 / yearp>Provide strategic and operational leadership for the development and execution of global biologics Regulatory CMC strategies for the responsible regions, including oversight of authoring, review, and lifecycle management of CMC sections of CTDs (Modules 2 and 3) for INDs, BLAs, MAAs, and post approval submissions. This role provides strategic and operational leadership for U.S.-based biologics Regulatory CMC activities and serves as a key partner to the China-based counterpart and global cross-functional stakeholders in the development and execution of global CMC regulatory strategies across the product lifecycle.
Associate Director, Regulatory Affairs, CMC BeOne Medicines AGAssociate Director, Regulatory Affairs, CMCNY$142,000–$192,000 / yearManage, prepare, and/or author CMC document packages for global regulatory submissions in support of development and lifecycle programs, including primary authorship and/or leadership of Module 3 (Quality) sections for INDs, CTAs, IMPDs, BLAs, MAAs, supplements, and variations. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity.
Senior Director/VP of Medical Affairs Click Therapeutics IncSenior Director/VP of Medical AffairsNY$180,000–$280,000 / yearConsistently named a best place to work, Click fosters an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in a common mission to provide patients everywhere access to safe and effective prescription digital therapeutics. Click Therapeutics may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons.
Manager, Regulatory Affairs, Advertising & Promotion Regeneron Pharmaceuticals IncManager, Regulatory Affairs, Advertising & PromotionNY$128,600–$210,000 / yearHelp lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions. Provide timely regulatory advice and guidance, with guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
Manager/Senior Manager, Regulatory Affairs Operations Axsome Therapeutics IncManager/Senior Manager, Regulatory Affairs OperationsNew York, NYRemote$120,000–$150,000 / yearOur industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members.
Regional Director, Field Medical Affairs - East Apogee Therapeutics IncRegional Director, Field Medical Affairs - EastEast, NY$250,000–$280,000 / yearApogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee's antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Regional execution of Medical Affairs strategy and objectives, ensure MSLs are equipped to engage with healthcare professionals (HCPs), KOLs, and other external stakeholders, delivering scientific and medical information that aligns with corporate strategy.
Senior Director, Medical Affairs Cellectis SASenior Director, Medical AffairsNY$175,000–$225,000 / yearReporting to the Chief Medical Officer, this leader will elevate Cellectis' scientific presence, support pipeline advancement, and ensure medical excellence in evidence generation, scientific communications, and external engagement. Cellectis is seeking a highly experienced Senior Director, Medical Affairs to help shape and operationalize the company's medical affairs strategy across its clinical-stage portfolio.
Senior Director, Medical Affairs Operations and Strategy Definium Therapeutics IncSenior Director, Medical Affairs Operations and StrategyNY$269,204–$295,000 / yearEstablish and oversee project management frameworks for all MA initiatives, including medical launches, clinical collaborations, evidence-generation programs, and scientific communication outputs. Responsibilities: In collaboration with Medical Affairs leadership, develop, operationalize, and continuously refine the Medical Affairs strategy, helping to translate strategic objectives into actionable project plans, KPIs and timelines.
Regional Government Affairs Director - Northeast ModivCare Inc.Regional Government Affairs Director - NortheastNY$159,900–$215,900 / yearThe position will design and implement state-level advocacy strategies aligned with enterprise priorities and will manage engagement with key stakeholders and execution of public affairs initiatives as directed and designed in collaboration with Corporate Affairs leadership. Serves as the companys primary representative at the assigned state capitols before executive leadership, including Medicaid directors, transportation program leaders, and personal care services (PCS) administrators.
Regional Government Affairs Director - Northeast ModivcareRegional Government Affairs Director - NortheastAlbany, New YorkThe position will design and implement state-level advocacy strategies aligned with enterprise priorities and will manage engagement with key stakeholders and execution of public affairs initiatives as directed and designed in collaboration with Corporate Affairs leadership. Serves as the company’s primary representative at the assigned state capitols before executive leadership, including Medicaid directors, transportation program leaders, and personal care services (PCS) administrators.
Senior Analyst, Regulatory Affairs Oscar Health IncSenior Analyst, Regulatory AffairsNYRemote$79,488–$104,328 / yearManage the end-to-end administrative lifecycle of each dispute by maintaining real-time updates on project management boards, gathering and redacting member documentation, and uploading supporting evidence to the appropriate portal stages within set regulatory deadlines. Work Location: This is a remote position, open to candidates who reside in: Arizona, Florida, Georgia, Illinois, Iowa, Kansas, Michigan, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Virginia.
Senior Medical Director, Medical Affairs, MASH Regeneron Pharmaceuticals IncSenior Medical Director, Medical Affairs, MASHNY$333,300–$450,900 / yearThis role might be for you if: • Must have an MD or MD equivalent with a preference for specialized fellowship training in Gastroenterology or Hepatology • 5 years of related industry experience in global or US medical affairs • Solid background and experience in drug development and life-cycle management • Experience with working in an alliance setting strongly preferred • Ability to lead technical and business discussions internally and externally and explain scientific/medical concepts to all levels • Ability to cultivate and maintain relationships with leading medical/scientific experts in the relevant fields • Ability to establish trust through the consistent demonstration of scientific expertise and satisfactory follow-through on requests from key opinion leaders • Strong leadership and management skills • Attention to detail in analyses, deliverables, and communications • Strong presentation and communication skills; must be able to provide succinct, strategic, and actionable insights to senior management • A proactive self-starter who can lead work and manage others independently, with the ability to see the next step and take actions without prompting • Ability to juggle multiple projects • Thorough understanding of the healthcare environment including all external stakeholders. A typical day in this role might look like: • Provides visionary leadership in the development, execution, and continuous refinement of medical strategy and tactics for assigned assets, ensuring alignment with corporate and global objectives.
Senior Analyst, Regulatory Affairs Oscar HealthSenior Analyst, Regulatory AffairsNew York City, NYRemote$79,488–$104,328 / yearManage the end-to-end administrative lifecycle of each dispute by maintaining real-time updates on project management boards, gathering and redacting member documentation, and uploading supporting evidence to the appropriate portal stages within set regulatory deadlines. Work Location: This is a remote position, open to candidates who reside in: Arizona, Florida, Georgia, Illinois, Iowa, Kansas, Michigan, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Virginia.
Director, Clinical Affairs Baxter International IncDirector, Clinical AffairsSkaneateles, NY$208,000–$286,000 / yearHigh experience/proficiency with clinical operations systems including EDC, CTMS, and eTMFAble to monitor performance of team in maintaining system updates to allow for senior management reportsApplies current applications/systems to compile information for presentation or distributionIdentifies new uses of current systems or use of new applications to enhance the management capabilities of projectsExpertise in clinical aspects of regulatory submission procedures, e.g. You will also provide leadership to the clinical affairs team, ensuring high‑quality study operations, safety oversight, and successful delivery of clinical evidence supporting Baxter's global portfolioWhat will you be doing- Clinical Strategy DevelopmentGather business priorities for both pre-market (approval) and post market (evidence) needs for clinical research.
Director, Scientific Communications - Lupus (Global Medical Affairs) Biogen IncDirector, Scientific Communications - Lupus (Global Medical Affairs)NY$186,000–$256,000 / yearp>About This Role: As a Director, Scientific Communications within the Global Medical Affairs Lupus Department, you will spearhead the development of the scientific narrative for general rheumatology and dermatology indications including Systemic Lupus Erythematosus (SLE) and Cutaneous Lupus Erythematosus (CLE), ensuring the story aligns with the unmet medical needs and the mechanism of the disease. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
Director, Field Medical Affairs (Neurology) Regeneron Pharmaceuticals IncDirector, Field Medical Affairs (Neurology)NY$205,000–$341,600 / yearAssists with management of clinical data through support of abstracts, posters, presentations and manuscript development to ensure rapid and accurate communication of scientific and clinical results. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
Associate Director, Field Medical Affairs- Allergy (eastern states) Regeneron Pharmaceuticals IncAssociate Director, Field Medical Affairs- Allergy (eastern states)NY$176,100–$287,300 / yearAs an Associate Director, Field Medical Affairs, you will serve as the primary scientific presence in your territory, engaging in meaningful exchange of clinical data and medical information with KOLs, HCPs, clinical research investigators, pharmacists, and other decision makers. For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.
Executive Director, Medical Affairs - Eosinophilic Esophagitis EoE Apogee Therapeutics IncExecutive Director, Medical Affairs - Eosinophilic Esophagitis EoENY$305,000–$340,000 / yearp>Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee's antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. This role also includes working closely with many cross-functional stakeholders, including but not limited to, clinical development, clinical operations, biometrics, research and translational medicine, regulatory affairs, business development and strategy, and commercial.
Quality Assurance and Regulatory Affairs Specialist EMED TechnologiesQuality Assurance and Regulatory Affairs SpecialistNew YorkLead/assist with Corrective and Preventative Action (CAPA) investigations, plan development and implementation of corrective actions, author CAPA reports, and ensure completion and accuracy of all associated Quality records. Administration of Document Control function, including document ID issuance, revision control, coordination of review and approval, communication of implementation tasks, and maintenance of all records.