Director of Regulatory Affairs SNF Holding CompanyDirector of Regulatory AffairsRiceboro, GeorgiaThe ideal candidate is a strategic thinker and people leader with deep regulatory expertise, strong cross-functional influence, and a proven ability to anticipate regulatory risk while supporting business growth. The Director of Regulatory Affairs & Product Stewardship is a senior leadership role responsible for defining, leading, and executing the Company’s global regulatory and product safety strategy.
Regulatory Affairs Manager Dentsply SironaRegulatory Affairs ManagerAnywhere, NYThis role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance. • Manages day-to-day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, and succession planning.
NewRegulatory Affairs Specialist - Contract TalentBurst, Inc.Regulatory Affairs Specialist - ContractTopeka, KS$34.87 / hourData Tracking & Reporting: Utilize Google Sheets to maintain trackers, manage logs, and ensure accurate, real-time visibility into the status of submissions. System Management: Use internal databases and digital tools (like SAP, AO Docs, and tracking systems) to maintain accurate compliance records.
NewDirector Regulatory Affairs - CMC Clinical Dynamix, Inc.Director Regulatory Affairs - CMCSan Diego, CAResponsible for the regulatory CMC leadership of one or more commercial and development projects, including responsibility for regulatory strategy, IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies with focus on the CMC aspects. Extensive project regulatory leadership and expertise, specifically focused on the CMC aspects for small molecules, biologics, and/or gene therapies.
NewQuality & Regulatory Affairs AxelonQuality & Regulatory AffairsGlenview, ILInvestigate customer/consumer complaints using root cause analysis and work with department managers to determine necessary corrective and preventive actions. Provide technical information and evaluate regulatory compliance of products while adhering to internal policies and guidelines for exporting products.
Regulatory Affairs Specialist AxelonRegulatory Affairs SpecialistTopeka, KSUtilize Google Sheets to maintain trackers, manage logs, and ensure accurate, real-time visibility into the status of submissions. Use internal databases and digital tools (like SAP, AO Docs, and tracking systems) to maintain accurate compliance records.
Document Control/Regulatory Compliance Coordinator - M PLS Staffing Solutions, IncDocument Control/Regulatory Compliance Coordinator - MBeverly, MA$60,000–$65,000 / yearFull timeResponsible for creation, organization, control, and maintenance of various core processes documentation (Engineering, Quality, and other Operations) in accordance with the company Quality Management System (QMS) procedures and policies. Regulatory Compliance will support the organization's Regulatory Affairs and Quality Assurance functions in multiple areas including documentation, compliance, audits and regulatory submissions.
NewFamily Nurse Practitioner / Physician Assistant - Flexible Schedules Fast Pace HealthFamily Nurse Practitioner / Physician Assistant - Flexible SchedulesTell City, INPosting Title: Family Nurse Practitioner / Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
NewFamily Nurse Practitioner / Physician Assistant - Growth Opportunity Fast Pace HealthFamily Nurse Practitioner / Physician Assistant - Growth OpportunitySmithville, TNPosting Title: Family Nurse Practitioner / Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
Senior Advisor, Regulatory and Clinical Affairs Carl Zeiss Meditec, IncSenior Advisor, Regulatory and Clinical AffairsSeattle, WA$183,000–$228,800 / yearFull timeThe individualis responsible forregulatory strategy andsupportofa variety of FDA submissionsincluding pre-submissions (Q-subs), pre-market notifications(510(k)s), pre-market approvalapplications (PMAs)andinvestigational device exemptions (IDEs). This roleacts as an advisorand subject matter expertfor US regulatoryand clinicalquestions, specifically interpreting US FDA's perspective,at all levels, from senior management to single contributors;for all functions (e.g.
Director, Medical Affairs (Nutrition) Fresenius Kabi USA, LLCDirector, Medical Affairs (Nutrition)Seattle, WA$185,000–$220,000 / yearFull timeThe Director, Medical Affairs will lead the field clinical education team and ensure that the respective territory engagement plans are effectively executed per defined targets, following Fresenius Kabi compliance rules and code of conduct and that relevant medical and scientific insight is routinely shared to optimize the Medical Affairs strategy for the nutrition portfolio. 3+ years of hands-on experience in patient care and in hospital and/or clinic and/or home infusion settings is required, with demonstrated expertise in clinical nutrition including experience in managing formula selection for oral nutritional supplement use and tube feeding regimens.
Senior Director - Global Regulatory Affairs - Global Regulatory Lead, Regulatory Strategy Eli Lilly and CoSenior Director - Global Regulatory Affairs - Global Regulatory Lead, Regulatory StrategyIndianapolis, IN$169,500–$248,600 / yearOur current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL). Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineRockville, MD$190,800–$300,300 / yearRequired Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
Program Manager, Regulatory Affairs Olympus CorpProgram Manager, Regulatory AffairsPAResponsible for maintenance of regulatory files and tracking databases toensure prompt and accurate access to company regulatory information and to provide reports to management concerning current, pending, and future approvals to management. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America.
Regulatory Affairs Specialist Zp Group LlcRegulatory Affairs SpecialistNCCoordinate with cross-functional teams including Regulatory Affairs, Quality, Manufacturing, Technical Operations, and CMC subject matter experts to gather and review submission content. Job Summary: Piper Companies is seeking a Regulatory Affairs Specialist I - CMC to support our end client''s Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs team.
Regulatory Affairs Specialist III Integrated Resources, IncRegulatory Affairs Specialist IIIMaplewood, MNAs a Regulatory Affairs & Product Stewardship Specialist within the Filtration & Separation business, you will support regulatory and product stewardship activities for a diverse portfolio of filtration, purification, bioprocessing, and life sciences products. This position plays a critical role in helping ensure products remain compliant, safe, and sustainable throughout their lifecycle while supporting business growth, innovation, and customer success.
Director, Regulatory Affairs – Global Regulatory Strategy Monte Rosa Therapeutics, IncDirector, Regulatory Affairs – Global Regulatory StrategyBoston, MassachusettsFull timeOverview: Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on immunology. Lead the preparation, submission, and maintenance of regulatory applications, including INDs, CTAs, marketing applications, Annual Reports, Orphan Drug Designation, Requests for Fast Track, and other regulatory documents.
Vice President Regulatory Affairs SABVice President Regulatory AffairsSioux Falls, SDFull timeDemonstrated experience in chemistry and manufacturing controls (CMC) and clinical issues and filings, including technology transfer, comparability, process validation, manufacturing changes, lifecycle management, and global regulatory submissions for biologic products. Demonstrated experience leading regulatory aspects of outsourced manufacturing and third-party CDMO partnerships, including technology transfer, CMC lifecycle management, manufacturing process and site changes and successful regulatory submissions.
Regulatory Affairs Specialist (CMC) Zp Group LlcRegulatory Affairs Specialist (CMC)Durham, NC$60,000–$85,000 / yearThe Regulatory Affairs Specialist is responsible for supporting global regulatory activities related to product development, registration, and lifecycle management of pharmaceutical products. This role ensures compliance with applicable regulatory requirements and provides strategic and operational support for CMC documentation and submissions across multiple regions.
Regulatory Affairs Specialist Sterigenics U.S.Regulatory Affairs SpecialistOak BrookWith a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. TRAINING REQUIRED: Regulatory Affairs Specialists must understand all aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes.
Principle Regulatory Affairs Strategy Associate Sunrise Systems IncPrinciple Regulatory Affairs Strategy AssociateLake Forest, CA$79.71–$83.33 / hourThe Principle Regulatory Affairs Strategy Associate, reporting to the Senior Director of Regulatory Affairs (LLSI), is primarily responsible for setting or executing the regulatory strategy, leading and managing, acting as a strategist, ensuring local product registration and facilitating health registration approvals, and supporting the Senior Director during due diligence and integration activities for Business Development & Licensing projects. Coordinate regulatory activities, including product submissions, renewals, and updates, by liaising with plants, agents, and governmental authorities to ensure timely submissions and approvalsOversee promotional material approval for Alcon ME/KSA portfolio, ensuring ethical conduct and compliance with national and international laws, codes, and regulations.
Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co IncDirector, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesRahway, NJ$210,400–$331,100 / yearRequired Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
Vice President, Regulatory Affairs Rhythm Pharmaceuticals IncVice President, Regulatory AffairsBoston, MA$260,000–$360,000 / yearThis leader will oversee a geographically diverse team responsible for execution of international regulatory affairs, regulatory operations, regulatory business operations, labeling, and CMC regulatory, while partnering closely with global regulatory strategy and cross-functional teams. Proven operational leadership with urgency and discipline, including experience leading high-performing teams, team leaders, and subject matter experts through growth, change, and increasing organizational complexity.
Principal Regulatory Affairs Specialist Elucent MedicalPrincipal Regulatory Affairs SpecialistEden Prairie, MinnesotaThe Principal Regulatory Affairs Specialist independently performs regulatory impact assessments for product design, manufacturing, labeling, software, process, supplier, and site changes; prepares technical documentation and regulatory submissions; supports implementation of regulatory pathways and strategies established by the Regulatory Affairs Director; and provides regulatory analysis to support product development, commercialization, change control, and post-market activities. Required: direct, hands-on experience preparing and supporting FDA 510(k)s for medical devices, including substantial equivalence documentation, submission compilation, FDA question responses, and clearance support.
NewQuality & Regulatory Affairs inSync StaffingQuality & Regulatory AffairsGlenview, IL$20–$20.59 / hourThe Quality & Regulatory Affairs Specialist works within the global Export Regulatory and Quality team to evaluate nutrition and regulatory compliance while supporting quality operations for Kraft Heinz products worldwide. " Investigate customer and consumer quality complaints using root cause analysis, collaborating with department managers to define corrective and preventive actions (CAPA).
Associate Director, Regulatory Affairs - Advertising & Promotion Xeris Biopharma Holdings IncAssociate Director, Regulatory Affairs - Advertising & PromotionChicago, IL$174,000–$232,000 / yearSignificant demonstrated experience developing and executing complex and innovative global regulatory strategies, assessing & communicating risk/benefit to senior management, and influencing organizational direction as it pertains to compliance of advertising and promotion materials. Provides leadership for and manages regulatory aspects of the copy review / approval process for promotional materials; ensures compliance of promotional materials with FDA laws, regulations, and published guidance documents.
Executive Director, Regulatory Affairs Kyverna Therapeutics IncExecutive Director, Regulatory AffairsRemote$270,000–$300,000 / yearThe ideal candidate is a seasoned regulatory leader with deep experience in advanced therapies who can shape regulatory strategy from early development through approval and launch, while partnering closely with Clinical, CMC, Commercial, Market Access, and Legal teams. The role requires the ability to translate scientific and clinical data into approvable, commercially viable labeling and to lead interactions with regulatory authorities, including FDA and global counterparts.
Regulatory Affairs Senior Director, Project Management Excellence Becton Dickinson Medical DevicesRegulatory Affairs Senior Director, Project Management ExcellenceProblem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, experience, wisdom, and advanced methods to make decisions and solve problems, demonstrating the ability to solve difficult problems and create effective and innovative solutions. Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of multiple simultaneous projects, enlisting resources to efficiently meet project needs.
Regulatory Affairs Project Manager Colgate-Palmolive CoRegulatory Affairs Project ManagerPiscataway, NJ$124,000–$174,000 / yearEstablished in 1806 as a small soap and candle business in New York City, Colgate-Palmolive is now a truly global company with products sold in over 200 countries and territories under such internationally recognized brand names as Colgate, Palmolive, Softsoap, Irish Spring, Protex, Sorriso, Kolynos, elmex, Tom's of Maine, Sanex, Ajax, Axion, Soupline, Haci Sakir, Suavitel, PCA SKIN, EltaMD, Filorga and Hello as well as Hill's Science Diet and Hill's Prescription Diet. Colgate-Palmolive is a leading consumer products company that serves hundreds of millions of consumers worldwide with brands and products across four core businesses - Oral Care, Personal Care, Home Care and Pet Nutrition.
Regulatory Affairs & Compliance Analyst, Policies & Procedures CalOptimaRegulatory Affairs & Compliance Analyst, Policies & ProceduresOrange, CA$68,015–$108,824 / yearWe are hoping you will join us as a Regulatory Affairs & Compliance Analyst, Policies & Procedures and help shape the future of healthcare where you'll be an integral part of our OOC - Policies & Procedures team, helping to strive for excellence while we serve our member health with dignity, respecting the value and needs of each of our members through collaboration with our providers, community partners and local stakeholders. Bachelor's degree in health services administration, public health, public policy or related field PLUS 3 years of experience in the health care industry in a public or regulatory affairs role, including experience in policies and procedures development, required; an equivalent combination of education and experience sufficient to successfully perform the essential duties of the position such as those listed above may also be qualifying.
Principal Regulatory Affairs Hamilton MedicalPrincipal Regulatory AffairsReno, NevadaFull timeThe initial focus of this role will be to ensure that regulatory files are compliant for 510(k), de Novo and PMA submissions; identify gaps in product documentation from 21 CFR Parts 800-1299 and EU MDR requirements; and ensure regulatory files are compliant with US regulatory requirements. This role is an integral part of our team and plays a pivotal role in securing clearance/approval/licensure on new devices, as well as ensuring our products meet regulatory requirements.
Sr Regulatory Affairs Specialist Quidelortho CorpSr Regulatory Affairs SpecialistQuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. Interacts with regulatory agencies regarding product registrations, licensures, and permits and supports regulatory compliance to QSR, ISO, CMDR, MDSAP, IVDD/IVDR, CFR and other worldwide regulatory requirements.
Regulatory Affairs Manager I Alcon IncRegulatory Affairs Manager ILake Forest, CAThe Manager I, Regulatory Affairs Strategy (Professional Path) ), reporting to the Senior Manager of Regulatory Affairs (LLSI), is primarily responsible for coordinating regulatory affairs activities, including product submissions, renewals, and updates, while ensuring compliance and competitive advantage. Collect and analyze regulatory intelligence for China to ensure product compliance and engage in industry associations like Advanced Medical Technology Association (AdvaMed) and Asia Pacific Medical Technology Association (APACMed).
Director, Clinical Research Regulatory Affairs University of Texas MD Anderson Cancer CenterDirector, Clinical Research Regulatory AffairsHouston, TXRemoteSuccessful completion of the LEADing Self Accelerate and/or LEADing Self Discover programs may substitute for one year of required supervisory or management experience Completion of both programs can be substituted for a maximum of two years of supervisory or management experience. Preferred: Demonstrated experience preparing and managing INDs and/or IDEs; familiarity with companion diagnostics and combination products is a plus, and an in-depth knowledge of FDA regulations, ICH guidelines, and GCP requirements, and an experience with EMA submissions.
Director, Regulatory Affairs (Product Development) Arthrex IncDirector, Regulatory Affairs (Product Development)Naples, FLMain Objective: The Director, Regulatory Affairs - Product Development is responsible for leading regulatory strategy and execution across Arthrex's product development portfolio, including new product introductions (NPIs), product modifications, and marketing material approvals. This individual will oversee a team of Regulatory Affairs managers aligned with major business units and serve as the senior regulatory partner to Engineering, Product Management, Clinical, Operations and Quality leadership.
Associate Director Regulatory Affairs Viridian Therapeutics IncAssociate Director Regulatory AffairsWaltham, MAReporting to the Senior Director, Regulatory Affairs, the Associate Director, Regulatory Affairs will represent Regulatory Affairs on assigned cross-functional teams and lead day-to-day regulatory activities for product development and approval in alignment with the corporate strategy for Viridian's Thyroid Eye Disease (TED) and TSHR portfolio. Communicate with internal and external stakeholders, including members of the leadership teams, to ensure cross-functional alignment, work with Regulatory CMC and Regulatory Operations teams to establish and meet timelines for regulatory submissions.
Director, Regulatory Affairs, Ex-US Larimar Therapeutics IncDirector, Regulatory Affairs, Ex-USPAProvide tactical advice to project teams, functional heads and other stakeholders to achieve timely and efficient program development, submissions and approval, while ensuring compliance with applicable global regulatory requirements • Lead regulatory submissions to ex-US health authorities (medicine regulatory and reimbursement groups) to ensure high-quality, timely submissions that align with Larimar's global regulatory strategy and plan • Collaborate with colleagues in Commercial, Medical, Legal, Compliance and other expertise areas in creation of advertising and promotional materials as assigned; and preparation of timely OPDP submissions • Prepare Larimar impact assessment of global regulatory intelligence including but not limited to ICH and global Health Authority guidances, global Health Authority Pilot programs and initiatives, rare disease product approvals, and FDA advisory committee meetings • Develop internal regulatory procedures and practices • Work closely with RA Sr. Requirements: Key Experience, Skills and Knowledge: • Minimum of 4-year undergraduate degree • 5 to 8 years' experience in a Regulatory Affairs role in the pharmaceutical industry, experience with EMA, MHRA and other local European agencies preferred • Understanding of GxP systems and Quality principles • Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies • Experience with preparation (authoring and review) of documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and global marketing authorization applications • Excellent communication, time management and project management skills • Continuous quality improvement mindset and attention to details • Can do attitude, flexibility, and mental agility.
Senior Manager, Regulatory Affairs Strategy Alcon IncSenior Manager, Regulatory Affairs StrategyLake Forest, CAManager, Regulatory Affairs Strategy (Professional Path), reporting to the Senior Director of Regulatory Affairs (LLSI), is primarily responsible for setting or executing the regulatory strategy, leading and managing, acting as a strategist, ensuring local product registration and facilitating health registration approvals, and supporting the Senior Director during due diligence and integration activities for Business Development & Licensing projects. In this role, a typical day will include: A self-starter, assertive leader who will be accountable for the End-to-End regulatory support for the anterior/posterior ophthalmologic products including, but not limited to, new products, sustaining legacy products, and improvements to the product lines.
Senior Associate Director, Global Regulatory Affairs CMC -NCE and/or NBE Boehringer IngelheimSenior Associate Director, Global Regulatory Affairs CMC -NCE and/or NBERidgefield, CT$170,000–$269,000 / yearIf you want to apply for the position in Germany , please use this link: Senior Regulatory Affairs Manager CMC for NBE Job Details | BoehringerPRD (https://jobs.boehringer-ingelheim.com/job/Biberach-Senior-Regulatory-Affairs-Manager-CMC-for-NBE-Germ/1271415301/) and/or Senior Regulatory Affairs Manager CMC for NCE Job Details | BoehringerPRD (https://jobs.boehringer-ingelheim.com/job/Biberach-Senior-Regulatory-Affairs-Manager-CMC-for-NCE-Germ/1271422201/). + Ensures that CMC regulatory requirements for variations are available in the change management system (Global Variation Database) and supports the CMC Change Coordinator in providing worldwide regulatory assessment of change applications, the Global Variation Database coordinator is responsible for the maintenance of the database.
Principal Regulatory Affairs Specialist Elucent Medical IncPrincipal Regulatory Affairs SpecialistEden Prairie, MN$120,000–$135,000 / yearThe Principal Regulatory Affairs Specialist independently performs regulatory impact assessments for product design, manufacturing, labeling, software, process, supplier, and site changes; prepares technical documentation and regulatory submissions; supports implementation of regulatory pathways and strategies established by the Regulatory Affairs Director; and provides regulatory analysis to support product development, commercialization, change control, and post-market activities. Required: direct, hands-on experience preparing and supporting FDA 510(k)s for medical devices, including substantial equivalence documentation, submission compilation, FDA question responses, and clearance support.
Regulatory Affairs Quality/Standards/Training Manager - Remote Roth Staffing CompaniesRegulatory Affairs Quality/Standards/Training Manager - RemoteAlameda, CaliforniaRemote$85–$93.68 / hourCollaborate with Quality Assurance and cross‑functional stakeholders to support health authority inspections across GPS and Regulatory Affairs, ensuring the RA function remains in a continuous state of inspection readiness. · Work with Regulatory Affairs Strategist, CRO and Clinical Operations to ensure the Trial Master File (TMF) and Veeva RIM is kept current and complete for Regulatory Affairs-related documents.
Senior Analyst - Compliance & Regulatory Affairs AXA SASenior Analyst - Compliance & Regulatory AffairsHARTFORD, CT$64,600–$107,300 / yearBy combining a comprehensive and efficient capital platform, data-driven insights, leading technology, and the best talent in an agile and inclusive workspace, empowered to deliver top client service across all our lines of business - property, casualty, professional, financial lines and specialty. You will report to the Manager Regulatory Compliance Services What you will BRING Were looking for someone who has these abilities and skills: Required Skills and Abilities Property & Casualty Insurance experience in the field of regulatory compliance, state filings, product development, underwriting or underwriting support.
Senior Director, Regulatory Affairs Policy, Regulatory Intelligence & Compliance Exelixis IncSenior Director, Regulatory Affairs Policy, Regulatory Intelligence & ComplianceAlameda, CAThe position oversees the surveillance, triage, interpretation, and dissemination of global regulatory intelligence across Research & Development (R&D), Quality (QA), Information Technology (IT) and Pharmaceutical Supply Chain (PSC), partnering with cross-functional subject matter experts to ensure impact assessments are conducted and documented. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: BA/BA degree in related discipline and 15 years of related experience; or, MA/MA degree in related discipline and 13 years of related experience; or, PhD in related discipline and 12 years of related experience; or, Equivalent combination of education and experience.
Director, Government & Regulatory Affairs (Hybrid - Washington D.C.,) BroadridgeDirector, Government & Regulatory Affairs (Hybrid - Washington D.C.,)District of ColumbiaReporting to the Head of Government Affairs, this individual will play a critical role in advancing Broadridge's policy priorities by building and maintaining relationships with key federal officials, monitoring legislative and regulatory developments, and positioning Broadridge as a trusted resource among policymakers and industry stakeholders. The ideal candidate brings deep knowledge of the financial services regulatory landscape, a strong network on Capitol Hill and within federal agencies, and the ability to translate complex regulatory issues into clear, compelling narratives for a variety of audiences.
Head of Quality & Regulatory Affairs, Endovascular Robotics Varian Medical Systems IncHead of Quality & Regulatory Affairs, Endovascular RoboticsNTN GR$238,300–$327,657 / yearIt is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.". In this role, you will: Own the Endovascular Robotics Regulatory Affairs strategy and operational implementation, overseeing all regulatory pathways across key markets (US, EU, etc) and leading the Quality organization ensuring compliance with all applicable regulations.
NewEntry Level Regulatory Affairs Specialist HarveStaffEntry Level Regulatory Affairs SpecialistChesterfield, MO$32.30–$40.30 / hourbody { font-family:'Times New Roman'; font-size:12pt } h1, h2, h3, p { margin:0pt } li { margin-top:0pt; margin-bottom:0pt } h1 { margin-top:12pt; page-break-inside:avoid; page-break-after:avoid; font-family:'Helvetica Neue'; font-size:16pt; font-weight:normal; color:#0079bf } h2 { margin-top:2pt; page-break-inside:avoid; page-break-after:avoid; font-family:'Helvetica Neue'; font-size:13pt; font-weight:normal; color:#0079bf } h3 { margin-top:2pt; page-break-inside:avoid; page-break-after:avoid; font-family:'Helvetica Neue'; font-size:12pt; font-weight:normal; color:#00507f }. This role manages regulatory documentation, maintains tracking systems, and coordinates with regulatory agencies to support timely product registrations.
Associate Labeling Specialist - Regulatory Affairs Applied Medical Resources CorpAssociate Labeling Specialist - Regulatory AffairsRancho Santa Margarita, CA$71,000–$80,000 / yearThe Associate Labeling Specialist works cross-functionally to support labeling projects from design input through final approval, making this an ideal opportunity for professionals with a background in regulatory affairs, quality assurance, or technical writing in the medical device industry. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.
Regulatory Affairs Specialist Singota SolutionsRegulatory Affairs SpecialistBloomington, IndianaRemote1. Conduct ongoing regulatory surveillance to proactively identify and address upcoming regulatory changes and collaborate with relevant departments to identify and implement necessary changes. Assist in the development and management of audit responses, working collaboratively across functions and ensuring accurate documentation and management of all audit records.
Director, Regulatory Affairs - Clinical LoyalDirector, Regulatory Affairs - ClinicalThe ideal candidate should be a strategic thinker that is comfortable owning complex, first-of-kind regulatory programs with limited precedent, possess deep working knowledge of FDA CVM clinical development pathways and submission requirements and thrive in an environment operating with a great deal of autonomy in setting direction, making judgement calls, and driving programs and regulatory pathways forward in an agile organization. We're pioneering a new category of veterinary prescription drugs that proactively and preventatively target the underlying drivers of aging, delaying the onset of disease and preserving quality of life as dogs age.
Executive Director, Regulatory Affairs, Advertising and Promotion Boehringer IngelheimExecutive Director, Regulatory Affairs, Advertising and PromotionRidgefield, CT$250,000–$394,000 / yearThe Executive Director oversees and develops a team of regulatory professionals specializing in Rx drug advertising and promotion, representing the function within the Regulatory Affairs leadership team and supporting global discussions, training, and alignment on U.S. FDA promotional requirements. The role provides strategic leadership across promotional review governance, shapes internal policy through participation in the Human Pharmaceuticals Review Committee, and strengthens regulatory intelligence through cross‑functional and external partnerships.