Regulatory Affairs Manager Dentsply SironaRegulatory Affairs ManagerSan Jose, CAThis 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.
Quality Assurance Assistant Manager of Regulatory Affairs Colony Brands, Inc.Quality Assurance Assistant Manager of Regulatory AffairsMonroe, WisconsinWhat You'll Do: In this highly collaborative role, you'll work with a team responsible for maintaining regulatory and product data while serving as a trusted resource to partners across R&D, Purchasing, Marketing, Operations, and other functional areas. What began as a premier mail-order cheese business has grown into a diverse portfolio of brands and products spanning food, apparel, home goods, and more.
Senior Manager, Regulatory Affairs West Pharmaceutical ServicesSenior Manager, Regulatory AffairsExton, PAWest solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. This role serves as a key bridge between regulatory experts, quality, commercial teams, and external clients to enable consistent, high‑quality execution of contracted regulatory deliverables.
NewRegulatory Affairs Specialist JouléRegulatory Affairs SpecialistTrumbull, CT$30–$35 / hourSkills — strong communication skills, ability to manage projects with cross functional teams, proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), SAP experience helpful. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.
Program Manager-PEG/DAG Public Affairs, Journeyman- WAX 1.4.06 CredenceProgram Manager-PEG/DAG Public Affairs, Journeyman- WAX 1.4.06Wright-Patterson Air Force Base, OHAssist in developing program management strategies to include recommending, initiating, reviewing, developing and implementing activities to accomplish Business Case Analysis (BCA), Cost of Ownership analysis (COO), aging aircraft analysis, process documentation, PWSs, Statement of Work (SOWs), Data Item Descriptions (DIDs), test plans, acquisition plans, Life Cycle Management Plans (LCMPs), Life Cycle Sustainment Plans (LCSPs) Engine Life Management Plans (ELMPs), Quality Assurance Surveillance Plans (QASPs), Acquisition Strategy Panels (ASPs), IMPs, IMSs, Aircraft Information Programs (AIPs), and Aircraft Information Management Plans (AIMPs). Support key acquisition events and reviews as needed, such as: System Requirements Reviews (SRRs), Preliminary Design Reviews (PDRs), Critical Design Reviews (CDRs), Test Readiness Reviews (TRRs), Technical Coordination Meetings (TCMs), Functional Configuration Audits (FCAs), Physical Configuration Audits (PCAs), Production Readiness Reviews (PRRs), Technical Interchange Meetings (TIMs), and others as applicable.
Legal Affairs Manager AmeripriseLegal Affairs ManagerCharlotte, NCCoordinates the creation, updating, and filing of registration statement post-effective amendments containing prospectuses and statements of additional information (SAIs) (including annual updates and supplements thereto) and other disclosure documents required by the Investment Company Act of 1940 ("1940 Act"), Securities Act of 1933 and the Securities Exchange Act of 1934. Responsibilities may also include providing legal and regulatory support for Columbia Threadneedle Investments’ investment advisory business, including those relating to: (i) the collective investment trusts; (ii) compliance with existing and new SEC regulations; (iii) various Ameriprise Financial entities and their related products or investments; and (iv) corporate governance matters.
Senior Manager, Medical Affairs Operations - Remote Agios PharmaceuticalsSenior Manager, Medical Affairs Operations - RemoteWashington DC, DCRemote$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.
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.
NewRates and Regulatory Manager - HYBRID - Relocation Package JobotRates and Regulatory Manager - HYBRID - Relocation PackageWinchester, KY$140,000–$215,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. This individual will play a critical role in supporting the company's financial and operational objectives by managing interactions with state regulatory agencies, developing cost-of-service studies, preparing rate filings, and ensuring compliance with regulatory requirements.
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.
Senior Director, Medical Affairs Waters CorporationSenior Director, Medical AffairsSan Diego, CAExperience in management of clinical and laboratory-based teams, leading teams remotely and managing projects effectively across geographical sites. • Develop and manage the Clinical Affairs team in support of clinical site selection, study design and execution of clinical trials and analytical validation studies to support regulatory and commercial goals.
Quality Systems & Regulatory Manager JobotQuality Systems & Regulatory ManagerLos Angeles, CA$90,000–$120,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. They’re looking for a tech-savvy and detail-oriented Quality Systems & Regulatory Manager to lead food safety systems, labeling accuracy, customer compliance documentation, and cross-functional audit readiness.
Associate Director, State Government Affairs - Remote Agios PharmaceuticalsAssociate Director, State Government Affairs - RemotePhiladelphia, PARemote$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.
Director Medical Affairs - Clinical Microbiology Waters CorporationDirector Medical Affairs - Clinical MicrobiologyAnywhere, MAThe Director is expected to bring deep diagnostic and laboratory expertise, strong business acumen, and a collaborative leadership style to advance medical credibility, innovation, and patient impact across Waters Advanced Diagnostics. This individual translates unmet customer and patient needs, evolving clinical practice, and real-world evidence into actionable medical strategies that strengthen product differentiation, support lifecycle decisions, and enable successful development and adoption of innovative diagnostic solutions.
Administrative Coordinator, Medical Affairs, Credentialing Verification Office, Full Time, Bethlehem St. Luke's Health Network, Inc.Administrative Coordinator, Medical Affairs, Credentialing Verification Office, Full Time, BethlehemBethlehem, PAFull timeIndividually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. Maintain close communication with CVO Manager and Supervisor, Medical Staff Officers, department and committee chairmen to ensure follow-through in change of hospital policy, medical staff policies and/or committee actions.
Quality Assurance / Quality Control Manager JobotQuality Assurance / Quality Control ManagerEagle Mountain, UT$95,000–$115,000 / yearThe ideal candidate will possess strong experience in dietary supplements, nutraceuticals, food manufacturing, or related regulated industries and have a proven track record managing supplier quality, GMP compliance, audits, CAPA programs, and quality systems. We are seeking an experienced Quality Assurance / Quality Control Manager to lead and continuously improve our Quality Management System across a growing portfolio of nutritional supplements, wellness products, and consumer packaged goods.
Engineer, Principal Regulatory Constellation EnergyEngineer, Principal RegulatoryWarrenville, IL$152,100–$169,000Understands interrelations and functions of various organizations (e.g., Nuclear Regulatory Commission (NRC), Institute of Nuclear Power Operators (INPO), Nuclear Energy Institute (NEI), North American Electric Reliability Corporation (NERC) etc.) related to nuclear power. Perform independent and in-depth research, reviews, studies and analyses to develop, manage and implement regulatory activities, related to plant safety, reliability, maintainability, and availability ensuring compliance to site's needs, regulatory requirements, and corporate policies.
General Operations Manager - B-1 Div (WBN) 1.2.07 CredenceGeneral Operations Manager - B-1 Div (WBN) 1.2.07Tinker Air Force Base, OKWorking knowledge of Air Force Records Information Management System (AFRIMS), Resource Management Information System (RMIS), DTS, SOCCER, MICT, PMRT, and the Education and Training Management System (ETMS). This division provides complete system management and ensures US airpower through acquisitions excellence by delivering modernization, sustainment, and support to the AF’s fleet of B-1 aircraft on-schedule and on-cost.
Manager, Global Vendor Quality, Global R&D & PV QA Daiichi Sankyo, Inc.Manager, Global Vendor Quality, Global R&D & PV QABasking Ridge, NJ$127,280–$190,920 / yearFull timeThis position focuses on operational execution, oversight, and continuous improvement of vendor quality activities, contributing subject-matter expertise while working under the direction of senior vendor quality leadership. The Manager, Global Vendor Quality (Global R&D & PV QA) supports the development, implementation, and execution of the GCP/GLP/GVP vendor quality program across Daiichi Sankyo group companies.
Sr Manager, Market Access - US - Medical Device JouléSr Manager, Market Access - US - Medical DeviceBlue Bell, PARemote$145,000–$180,000 / yearThe ideal candidate has owned the market access role during a product launch in the US market and has worked in close collaboration with other business functions (medical affairs, governmental affairs, legal, regulatory, marketing and sales) in prior roles. Leads all aspects of Market Access actions in North America Works cross-functionally with Clinical Affairs, Regulatory Affairs, Governmental Affairs, Commercial, Medical Affairs and Regional Marketing colleagues in North America.
NewSenior Manager, Food Safety & Quality Compliance Treehouse FoodsSenior Manager, Food Safety & Quality ComplianceOak Brook, IL$124,800–$187,200 / yearAn employee's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, seniority, geographic location, performance, shift, travel requirements, sales or revenue-based metrics and business or organizational needs. Provide technical guidance to facility and warehouse personnel in developing systems, knowledge, and practices to ensure compliance with food safety regulations, company policies, and external audits (including customer, certification, GFSI, and regulatory).
Operations Management Analyst F-35 - 1.1.02 CredenceOperations Management Analyst F-35 - 1.1.02WPAFB, OHThese tasks include: tracking manning and preparing organizational charts; data entry functions; integrating information into required reports; generation and maintenance of training requirements, files, forms and established file plans; processing mail; (receive, sign for, and distribute unclassified mail, and access, store, and handle classified material as required); preparing correspondence (both classified and unclassified); management and operation of facsimile equipment. Interact with lateral organizations or any external agencies required including base facility, personnel, security, computer support, foreign disclosure, foreign travel, public affairs and the building managers to facilitate uninterrupted day-to-day operations of the organization.
NewProject/Product Manager III CYNET SYSTEMSProject/Product Manager IIIPomona, CA$66–$83 / hourPart timeDemonstrated success project managing complex, cross-functional initiatives, including the development and delivery of strategic investment plans, regulatory filings (e.g., GRC, RAMP, WMP), or other executive- and regulator-facing documentation. As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers.
Product Manager Capgemini Government Solutions LLCProduct ManagerMcLean, VAThe disclosed range takes into account the wide range of factors that are considered in making compensation decisions including, but not limited to, geographic location, relevant education, qualifications, certifications, experience, skills, seniority, performance, sales or revenue-based metrics, and business or organizational needs. Demonstrated experience managing IT-related projects and end-to-end product lifecycles, including defining user needs, shaping roadmaps, prioritizing features, and ensuring value delivery across iterative releases.
Director of Quality & Regulatory Affairs Silgan Dispensing SystemsDirector of Quality & Regulatory AffairsSpokane, WA$180,000–$180,000.01 / yearFull timeSilgan Unicep Packaging, a Silgan Dispensing company, is a premier liquid, gel, and cream contract manufacturer specializing in compounding/mixing, contract filling and designing custom unit-dose blow-fill-seal dispensers, Silgan Unicep serves a variety of customers in the medical diagnostic and imaging, consumer healthcare, oral healthcare, animal health markets. Reporting directly to the General Manager, the DQR ensures that all subcontracted and internal manufacturing activities meet current Good Manufacturing Practices (cGMP) and client-specific requirements while managing the lifecycle of drug, device, and cosmetic products from incoming materials to final product release.
Director, Regulatory Strategy (Pediatrics) - Remote Agios PharmaceuticalsDirector, Regulatory Strategy (Pediatrics) - RemoteAustin, TXRemote$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.
NewBanking Center Manager First Horizon BankBanking Center ManagerGermantown, TNHeadquartered in Memphis, TN, the banking subsidiary First Horizon Bank operates in 12 states across the southern U.S. The Company and its subsidiaries offer commercial, private banking, consumer, small business, wealth and trust management, retail brokerage, capital markets, fixed income, and mortgage banking services. First Horizon Corporation is a leading regional financial services company, dedicated to helping our clients, communities and associates unlock their full potential with capital and counsel.
Banking Center Manager II First Horizon BankBanking Center Manager IIDurham, NCHeadquartered in Memphis, TN, the banking subsidiary First Horizon Bank operates in 12 states across the southern U.S. The Company and its subsidiaries offer commercial, private banking, consumer, small business, wealth and trust management, retail brokerage, capital markets, fixed income, and mortgage banking services. First Horizon Corporation is a leading regional financial services company, dedicated to helping our clients, communities and associates unlock their full potential with capital and counsel.
Maintenance Manager (Food Manufacturing) CONAGRAMaintenance Manager (Food Manufacturing)Menomonie, WI$82,000–$120,000Reporting to the Plant Manager at our Menomonie, Wisconsin plant, you will lead the maintenance function to ensure reliable, efficient manufacturing operations while minimizing downtime and sustaining peak plant performance. When visiting these sites, the physical requirements below may apply: You may be required to walk around the facility, climb stairs/ladders, kneel, or perform repetitive tasks that require hand-eye coordination.
NewSenior Product Manager - Remote IntradoSenior Product Manager - RemoteAnywhere, NYRemote$120,000–$150,000 / yearWorking within Intrado’s product operating model, you will partner closely with Sales, Customer Success, Engineering, Network Operations, Product Operations, Regulatory Affairs, and telecommunications service providers to define and deliver solutions that meet evolving customer, industry, and regulatory requirements. The ideal candidate brings experience in telecommunications, emergency communications, or network-based services and has a strong understanding of Wireline, VoIP, NG911, location information services, and the public safety ecosystem.
NewAnalytical Science Manager JouléAnalytical Science ManagerParsippany, NJ$100,000–$135,000 / yearSystem One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. Partner with Quality Assurance, Regulatory Affairs, and external test sites to support technology transfers, and analytical method validations.
ITAR Manager - Compliance Michael Page USAITAR Manager - ComplianceBarrington, NH$90,000–$110,000 / yearFull timeThe role blends strategic oversight with practical execution, requiring someone who can both create frameworks and personally drive remediation, audits, and ongoing compliance operations. This is a hands-on ITAR Compliance Manager position responsible for designing, building, and executing a full export compliance programme across the organisation.
Project Manager II Waters CorporationProject Manager IIMilford, MAAs a Project Manager II, you will partner closely with Product Management, Engineering, Operations, and other cross-functional teams to ensure projects are delivered on time, within scope, and aligned with portfolio priorities. • Support and manage cross-functional project teams including Product Management, Engineering, Operations, Regulatory Affairs, Quality Assurance, and Finance.
Manager, Forensic Technology TeneoManager, Forensic TechnologyNew York, NY$100,000–$170,000 / yearOur full range of advisory services includes strategic communications, investor relations, financial transactions and restructuring, management consulting, physical and cyber risk, organizational design, board and executive search, geopolitics and government affairs, corporate governance, ESG and DE&I. • Take ownership of end-to-end matter delivery while strengthening team capability, optimising forensic technology and eDiscovery workflows, and contributing to business development and client growth initiatives.
Senior Manager, Forensic Technology TeneoSenior Manager, Forensic TechnologyNew York, NY$150,000–$220,000 / yearOur full range of advisory services includes strategic communications, investor relations, financial transactions and restructuring, management consulting, physical and cyber risk, organizational design, board and executive search, geopolitics and government affairs, corporate governance, ESG and DE&I. 8+ years of forensic technology experience in a consulting environment preferably gained at a Strategy or Management Consulting firm, Big 4 or corporate internal consulting function.
NewCivic Advocacy Manager Lenox Hill Neighborhood HouseCivic Advocacy ManagerNew York, NYLenox Hill Neighborhood House, widely recognized as one of New York’s premier human services providers, is a settlement house founded in 1894 that provides an extensive array of effective and integrated services—social, educational, health, housing, mental health, nutritional and fitness—which significantly improve the lives of 16,000 people each year, ages 3 to 100-plus, on the East Side of Manhattan and across New York City. Interpersonal and communication skills necessary to work directly with a wide range of key stakeholders, including clients, government agencies, elected officials, nonprofit partners, advocates, policy experts and other individuals and organizations in our community.
NewInnovation Strategy Manager GrifolsInnovation Strategy ManagerBoca Raton, FLAs the head of the Plasma Innovation Hub, this role defines strategic innovation priorities, manages high‑impact projects, and drives cross‑functional experimentation that contributes to the transformation of the donor and plasma value chain. Reporting to the Head of Business Development & Plasma Affairs, the Strategy Manager oversees the Innovation vertical and collaborates closely with global stakeholders to ensure initiatives deliver measurable business value and operational improvements.
NewFamily Nurse Practitioner / Physician Assistant - Growth Opportunity Fast Pace HealthFamily Nurse Practitioner / Physician Assistant - Growth OpportunityGreenbrier, 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.
NewFamily Nurse Practitioner / Physician Assistant - Flexible Schedules Fast Pace HealthFamily Nurse Practitioner / Physician Assistant - Flexible SchedulesGreenbrier, 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.
Clinical Assessment Manager-Manhattan/Queens or Brooklyn-Bilingual Chinese Speaking Required VNS HealthClinical Assessment Manager-Manhattan/Queens or Brooklyn-Bilingual Chinese Speaking RequiredNew York, NY$85,000–$106,300Performs in-home assessment for members who have identified significant changes in condition since last in-home assessment; provides comprehensive review and determination of member’s needs, including completion of UAS assessment questionnaire, tasking tool, and a projected service plan. We’re one of the largest nonprofit home- and community-based health care organizations in the country, and today, more than 11,500 team members work together to make a difference in the lives of more than 99,000 patients and members on any given day.
Senior Director, Program Leader, Corporate Strategy Agios PharmaceuticalsSenior Director, Program Leader, Corporate StrategyCambridge, MA$229,562–$344,345 / yearDemonstrated ability to drive successful product launch and commercialization of innovative, first-in-class therapies, including lifecycle management (LCM) planning and execution; experience leading programs from late-stage development through commercial readiness and post-launch LCM strategies strongly desired. Define and continuously evolve the Target Product Profile, Clinical Development Plan, regulatory pathway, market access strategy, and commercial positioning in close partnership with cross-functional leaders and aligned with patient needs.
Regulatory Affairs Manager Huisong PharmaceuticalsRegulatory Affairs ManagerSanta Ana, California$38–$48Position Overview Huisong Inc. is seeking an experienced Regulatory Affairs Manager to support regulatory strategy and compliance for dietary supplements, botanical ingredients, herbal extracts, and Traditional Chinese Medicine products. Founded in 1998, Huisong Pharmaceuticals specializes in the research, development, and manufacturing of premium-quality natural ingredients for leading companies in the pharmaceutical, nutraceutical, food and beverage, and personal care industries.
Regulatory Affairs Manager The Ritedose CorporationRegulatory Affairs ManagerColumbia, SCFull time5+ years regulatory affairs experience; FDA submission experience required, experience with device and/or drug/device combination products preferred . The Regulatory Affairs Manager will ensure compliance with regulatory requirements and manage lifecycle activities in alignment with the Director of Regulatory Affairs.
NewRegulatory Affairs Manager III Integrated Resources, IncRegulatory Affairs Manager IIILower Gwynedd Township, PennsylvaniaContractorHe/she will possess a quality mindset; have Quality Systems/Quality Management experience across GXPs (specifically desirable: adequate knowledge of GCP/clinical trial development; Pharmacovigilance principles and GLP/pre-clinical activities)Principal Responsibilities:Provide project management expertise and skills to all L&A activities and deliverables including metrics/dashboard updates and maintenance of the L&A Tracker and corresponding document libraries; provide guidance on tracking mechanisms & meeting structures. supporting deviation/CAPA Management Processes for L&A Assessment Activities; supporting various administrative and operational aspects of BRQC 90/100 Day Assessment Plans (90/100DPs) for incoming opportunities as well as support/manage opportunities that fall outside the scope of typical L&A (funding opportunities, collaborations, etc.).
Regulatory Affairs Manager Transpire BIO Inc.Regulatory Affairs ManagerSunrise, FLThe Regulatory Affairs Manager independently and without appreciable direction, actively collaborates with R&D to author, prepare, review and submit high-quality regulatory submissions and communications within company timelines and in accordance with regulatory guidelines and applicable laws; acts as the company contact with FDA. Represent the Regulatory Affairs group in project team meetings and provide regulatory guidance and perspective to team members in determining appropriate actions in order to meet scheduling timelines and/or in resolving technical issues.
Regulatory Affairs Manager Gateway RecruitingRegulatory Affairs ManagerSan Jose, CAThe candidate will combine knowledge of scientific, regulatory, and business issues to enable products, including combination products, that are developed, manufactured or distributed to meet required legislation. 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related areas.
NewRegulatory Affairs Manager (Expanded Access Programs) Impatients NVRegulatory Affairs Manager (Expanded Access Programs)You will be actively working together with Medical Affairs, Program Management, Quality Assurance, and Supply Chain and will report to the Director of Regulatory Affairs and Pharmacovigilance (Emily says hi). What you will do in this role: Support the development and execution of regulatory strategies for Expanded Access Programs (EAPs) involving biologicals, cell therapies, and synthetic drugs.
NewRegulatory Affairs Manager Integrated Resources, IncRegulatory Affairs ManagerWoodcliff Lake, New JerseyFull timeJob DescriptionJob Position: Global Regulatory Affairs – Strategy ManagerDuration: Fulltime PermanentManager, Global Regulatory Strategy (GRS) will be a forward-facing role, representing GRS on project teams and communicating strategic options, issues and risks to a broad range of Stakeholders in an end-to-end pharmaceutical business model (R&D through commercial).The candidate will have the opportunity to research, develop and implement regulatory strategies to facilitate global approval of new medicinal products. Candidate should be comfortable working independently to create Health Authority correspondence (including request for Health Authority consultations), and attending specific project team meetings (such as Clinical Study Team Meetings) as the Regulatory Affairs Representative and providing guidance to project teams on all areas of pharmaceutical drug development (ICH, 21CFR).A working knowledge of relevant drug laws, regulations and guidance's/guidelines is highly desirable.
Regulatory Affairs Manager Katalyst Healthcares & Life SciencesRegulatory Affairs ManagerBaltimore, MDProvide leadership to Subject Matter Experts (SMEs) in multidisciplinary teams and manage day to-day operations of project tasks/activities to ensure deliverables are met in a timely manner within budget. Experience with multiple electronic software/platforms (such as Vantagepoint, Starting Point templates (or similar regulatory templates), Smartsheet, MS Office suite or other project management programs).