Current jobs related to Senior Manager, Regulatory Operations - Frankfort - Sumitomo Pharma

  • Lead Manager, Regulatory Affairs Operations

    1 week ago

    Frankfort, Kentucky, United States Takeda Pharmaceuticals Full time

    Takeda Pharmaceuticals - Lead Manager, Regulatory Affairs OperationsPosition Overview:In the role of Lead Manager, Regulatory Affairs Operations, you will play a pivotal part within the Vaccine Business Unit (VBU) to enhance the vision of Regulatory Operations. Your focus will be on supporting health authority submissions, registrations, and archival...

  • Facilities Operations Manager

    1 week ago

    Frankfort, Kentucky, United States Dominion Senior Living Full time

    The Dominion Difference Are you prepared to become part of a vibrant team united by a common goal to positively influence the lives of seniors while adhering to our faith-based principles? At Dominion Senior Living, we offer more than just a position - we present an opportunity to engage in something profoundly rewarding. Our innovative culture-first...

  • Caregiver for Seniors

    1 week ago

    Frankfort, Kentucky, United States Dominion Senior Living Full time

    Position Overview Role Summary Join the Dominion Senior Living Team Are you eager to become part of a compassionate team dedicated to enhancing the lives of seniors while adhering to our core values? At Dominion Senior Living, we offer more than just a position – we provide a chance to engage in a rewarding experience. Our culture-first philosophy...

  • Senior Environmental Engineer

    1 week ago

    Frankfort, Kentucky, United States Weaver Consultants Group Full time

    Job OverviewLocationFrankfort, KYEmployment TypeFull TimePosition SummarySenior Environmental EngineerWeaver Consultants Group is seeking a Senior Environmental Engineer with 0 to 3 years of experience, passionate about environmental and civil engineering. This role focuses on the design, implementation, construction, monitoring, assessment, regulatory...

  • Senior Management Analyst

    2 months ago

    Frankfort, United States Strategic Resources Inc Full time

    Senior Management Analyst Job Description Strategic Resources, Inc. (SRI) is an international, ISO 9001:2015 Certified, CMMI Level 3 Rated full-service provider with more than 34 years’ experience in the Federal, Military, and Commercial Marketplaces. SRI is seeking committed and passionate professionals to provide professional services and management...

  • MDS Nursing Coordinator

    3 days ago

    Frankfort, Indiana, United States BHI SENIOR LIVING, INC. Full time

    Position Overview at BHI Senior Living, Inc.The MDS Nursing Coordinator role is now available. We are looking for a committed RN or LPN who is eager to contribute to a fulfilling career path. BHI Senior Living, Inc. is in search of an enthusiastic and skilled individual to enhance our nursing leadership team as an MDS Coordinator.What We ProvideCompetitive...

  • Paramedic Operations Manager

    16 hours ago

    Frankfort Springs, Pennsylvania, United States FirstHealth of the Carolinas Full time

    Job Summary:FirstHealth of the Carolinas is seeking a highly skilled EMS Senior Paramedic to join our team. As a key member of our operations team, you will be responsible for providing advanced life support emergency/non-emergency care at the paramedic level in the pre-hospital environment and during ambulance transport of patients.Key...

  • Treasury Operations Manager

    1 week ago

    Frankfort, Kentucky, United States Norstella Full time

    Position: Senior Treasury AnalystAt Norstella, we are dedicated to expediting the delivery of life-saving therapies to patients in need. Our rich history, which dates back to 1939, has culminated in the establishment of Norstella in 2022, where we unite premier brands to guide clients through the intricate drug development process.As a Senior Treasury...

  • Senior Representative, Customer Service Operations

    3 weeks ago

    Frankfort, United States Cardinal Health Full time

    What Customer Service Operations contributes to Cardinal Health Customer Service is responsible for establishing, maintaining and enhancing customer business through contract administration, customer orders, and problem resolution. Job Summary The Senior Representative, Customer Service Operations is responsible for providing outstanding customer service and...

  • Senior Compliance Professional

    4 days ago

    Frankfort, Kentucky, United States Humana Full time

    Job SummaryWe are seeking a highly skilled Senior Compliance Professional to join our team at Humana. As a key member of our compliance team, you will be responsible for ensuring that our Medicare and Commercial Dental and Vision products in Puerto Rico are in compliance with regulatory requirements.Key Responsibilities:Subject Matter Expertise: Serve as a...

  • Geologist with Regulatory Expertise

    1 week ago

    Frankfort, Kentucky, United States Kentucky Personnel Cabinet Full time

    Position OverviewThe Kentucky Personnel Cabinet is seeking a Registered Geologist to join our dedicated team within the Energy & Environment Cabinet. This role is integral to our mission of enhancing the quality of life for all Kentuckians by safeguarding our natural resources.Key ResponsibilitiesAs a Registered Geologist, you will:Conduct thorough...

  • Area Operations Manager

    1 week ago

    Frankfort, Kentucky, United States Magellan Health Full time

    Position Overview:The Area Operations Manager serves as a key leader within the organization, overseeing the effective delivery of services and management of personnel across various projects. This role is pivotal in ensuring operational excellence and strategic alignment with organizational goals.Key Responsibilities:Act as a deputy to the program manager,...

  • Senior Geologist

    4 days ago

    Frankfort, Kentucky, United States Kentucky Personnel Cabinet Full time

    Position OverviewThe Kentucky Personnel Cabinet is seeking a dedicated Senior Geologist to join our team. This role is essential in ensuring the protection of our natural resources through comprehensive geological assessments and regulatory compliance.Key ResponsibilitiesConduct in-depth geological evaluations of waste management applications to ensure...

  • Senior Cash Management Specialist

    1 week ago

    Frankfort, Kentucky, United States Norstella Full time

    Position: Senior Treasury AnalystAt Norstella, we are dedicated to accelerating the delivery of life-saving therapies to patients who need them most. Our legacy, which began in 1939, has evolved into a unified entity established in 2022, bringing together premier brands to assist clients in navigating the intricate drug development landscape.As a Senior...

  • Operations Manager

    1 week ago

    Frankfort, Kentucky, United States Vulcan Materials Full time

    Position Overview - Operations ManagerAs an Operations Manager at Vulcan Materials Company, you will play a crucial role in overseeing the production processes within our facilities. Vulcan Materials is recognized as the leading provider of construction aggregates in the United States, and our commitment to quality and safety is paramount.Key...

  • Senior Microsoft Developer

    4 weeks ago

    Frankfort, United States Connvertex Technologies Inc. Full time

    Job DescriptionJob DescriptionSenior Microsoft DeveloperJOB DESCRIPTION:The project involves supporting and re-platforming existing smart eForms (Microsoft Webforms) to MVC. The cabinet has been using these smart forms since 2007 for most agencies within the cabinet. Industry and public use eForms to submit regulatory data using eForms which include...

  • Senior Microsoft Developer

    4 weeks ago

    Frankfort, United States Apex Systems Full time

    Apex Systems is seeking to hire a Senior Microsoft Developer to join our client's regulatory team. In this role you'll act as a senior individual contributor, utilizing a C#, .NET stack to support web applications involved in critical reporting.Location: Frankfort, KY | 2 days on site per week to begin, eventually transitioning to 1 day on site per...

  • Senior Microsoft Developer

    4 weeks ago

    Frankfort, United States Apex Systems Full time

    Apex Systems is seeking to hire a Senior Microsoft Developer to join our client's regulatory team. In this role you'll act as a senior individual contributor, utilizing a C#, .NET stack to support web applications involved in critical reporting.Location: Frankfort, KY | 2 days on site per week to begin, eventually transitioning to 1 day on site per...

  • Senior Land Surveying Manager

    1 week ago

    Frankfort, Kentucky, United States W3Global Inc Full time

    Job OverviewPosition SummaryAs a Senior Land Surveying Manager at W3Global Inc, you will lead the surveying division, focusing on business growth across various surveying disciplines including boundary determination, construction layout, ALTA surveys, drone applications, topographical mapping, and subdivision planning. Your leadership will be pivotal in...

  • QFS Manager

    3 weeks ago

    Frankfort, United States ADM Full time

    Job Description QFS Manager - Frankfort, INThis is an exempt level position.Job Summary: The QFS (Quality and Food Safety) Manager is responsible for the daily quality control and quality analysis of the facility's inbound/outbound products and ingredients and is responsible for managing the site's food safety program. The plant operates twenty four hours a...

Senior Manager, Regulatory Operations

1 month ago

Frankfort, United States Sumitomo Pharma Full time

Location field must contain 'city, state' or a zip code to perform a radius search (e.g., Denver, CO or 46122 ). City and state must be separated by a comma followed by a space (e.g., Houston, TX ). Sumitomo Pharma Senior Manager, Regulatory Operations Frankfort, Kentucky Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Regulatory Operations. For assigned projects, the Senior Manager of Regulatory Operations is responsible for managing all Regulatory Affairs activities involving compilation, publishing, distribution, and archiving of health authority submissions. Job Duties and Responsibilities Overseeing the external Submission Managers with defining submission outlines, content, format, and quality requirements for electronic submissions, with input from Regulatory Affairs staff as needed. Manages the external submission Managers to ensure the accurate and timely management of the tracking, compiling, publishing, quality checking, dispatching and archiving of Health Authority submissions. Facilitates submission preparation via completion of forms and creation of cover letters. Represents Regulatory Operations on project teams for matters relating to electronic (and paper) submissions. Overseeing the external Submission Managers to ensure accurate printing, distributing, and archiving all incoming and outgoing communications with FDA and international counterpart agencies. Leads in the implementation, validation, and operation of eCTD and electronic document management systems and other publishing and submissions technology projects. Leads the development, refinement, and implementation of internal processes, procedures, work instructions and training programs for submission production and operational support activities. Understands evolving Health Authority (HA) standards and procedures for regulatory submissions. Coordinating and consulting with other departments on the content, review, and assembly of regulatory documentation. Assisting in the creation of regulatory project plans and timelines for multiple projects or developmental programs. Leads the training of appropriate R&D staff in the application of various standards and technologies. Key Core Competencies Detail-oriented self-starter with excellent organizational, planning, and follow-up skills. Ability to meet tight competing deadlines, juggle multiple priorities and multi-task. Extensive knowledge of regulatory submission publishing standards and procedures. Thorough understanding of FDA and other health agency regulations and guidance governing submission content and format. Education and Experience High School (Bachelor’s degree preferred) Minimum 8 years (w/o Master’s) or 6 – 8 years (with Master’s) years of relevant experience in biotech or pharmaceutical industry. 7+ years’ experience in a fast-paced, high-volume document production environment. Compensation The base salary range for this role is $126,600 to $155,000. Base salary is part of our total rewards package which also includes various benefits. Confidential Data : All information encountered is considered confidential. Compliance : Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures. Mental/Physical Requirements : Fast-paced environment handling multiple demands. Requires a high level of initiative and independence. Equal Employment Opportunity : Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer. For more information about EEO and the Law, please visit the following pages: Equal Employment Opportunity is THE LAW EEO is the Law Poster Supplement At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values. Our Mission : To broadly contribute to society through value creation based on innovative research and development activities. Our Vision : For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas. #J-18808-Ljbffr