78 regulatory affairs associate jobs found

Description: Larimar is seeking a Regulatory Affairs Associate Director to support the global regulatory strategy and regulatory activities for products in development. The Regulatory Affairs Associate Director will be a key member of project teams. The role reports to the Regulatory Affairs Senior Director. Job Duties/Responsibilities: Interface with other Larimar departments and outside consultants to obtain timely regulatory deliverables and ensure regulatory compliance Advise other departments on regulatory health authority requirements for product development and regulatory submissions Plan, author and review high quality regulatory submissions May serve as back up to Regulatory Operations for filing regulatory submissions Maintain ongoing awareness of global regulations and guidelines relevant to projects Develop internal regulatory procedures and practices Requirements: Minimum of 4-year undergraduate degree 8+ years experience in a Regulatory...

Job Description A collective energy and ambition. A place where you can make a real difference. We’re a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries. United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win. Role Summary                                                           Possesses and maintains up-to-date knowledge of regulatory requirements relative to products and areas of responsibility as assigned.  Responsible for electronic reporting and registration activities and to provide support for...

Job Description A collective energy and ambition. A place where you can make a real difference. We’re a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries. United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win. Role Summary                                                           Possesses and maintains up-to-date knowledge of regulatory requirements relative to products and areas of responsibility as assigned.  Responsible for electronic reporting and registration activities and to provide support for...

Job Description A collective energy and ambition. A place where you can make a real difference. We’re a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries. United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win. Role Summary                                                           Possesses and maintains up-to-date knowledge of regulatory requirements relative to products and areas of responsibility as assigned.  Responsible for electronic reporting and registration activities and to provide support for...

Job Description A collective energy and ambition. A place where you can make a real difference. We’re a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries. United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win. Role Summary                                                           Possesses and maintains up-to-date knowledge of regulatory requirements relative to products and areas of responsibility as assigned.  Responsible for electronic reporting and registration activities and to provide support for...

Job Description A collective energy and ambition. A place where you can make a real difference. We’re a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries. United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win. Role Summary                                                           Possesses and maintains up-to-date knowledge of regulatory requirements relative to products and areas of responsibility as assigned.  Responsible for electronic reporting and registration activities and to provide support for...

Job Description A collective energy and ambition. A place where you can make a real difference. We’re a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries. United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win. Role Summary                                                           Possesses and maintains up-to-date knowledge of regulatory requirements relative to products and areas of responsibility as assigned.  Responsible for electronic reporting and registration activities and to provide support for...

Job Description A collective energy and ambition. A place where you can make a real difference. We’re a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries. United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win. Role Summary                                                           Possesses and maintains up-to-date knowledge of regulatory requirements relative to products and areas of responsibility as assigned.  Responsible for electronic reporting and registration activities and to provide support for...

Job Description A collective energy and ambition. A place where you can make a real difference. We’re a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries. United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win. Role Summary                                                           Possesses and maintains up-to-date knowledge of regulatory requirements relative to products and areas of responsibility as assigned.  Responsible for electronic reporting and registration activities and to provide support for...

Job Description A collective energy and ambition. A place where you can make a real difference. We’re a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries. United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win. Role Summary                                                           Possesses and maintains up-to-date knowledge of regulatory requirements relative to products and areas of responsibility as assigned.  Responsible for electronic reporting and registration activities and to provide support for...

Job Description A collective energy and ambition. A place where you can make a real difference. We’re a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries. United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win. Role Summary                                                           Possesses and maintains up-to-date knowledge of regulatory requirements relative to products and areas of responsibility as assigned.  Responsible for electronic reporting and registration activities and to provide support for...

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Attention: If you are a current Alexion employee, please apply via Alexion's internal Life & Career portal. . Note that you will need to be connected to the VPN if you are applying away from the office. Alexion does not contact candidates via instant messaging or chat tools. At no time will we ask candidates for fees associated with obtaining software, nor do we provide employees with a cashier's check to purchase new equipment. If you are contacted in this manner, please be aware that it is fraudulent, and please do not provide any information or money to these individuals. Applicants should only apply through this Alexion website. Any fraudulent activity should be reported to GSOC@alexion.com Req ID: 31134 Job Category: Regulatory Affairs New Haven, CT Posting Date: March 2, 2023 Some opportunities happen only once in a lifetime – like a job where you have the...

About Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines. Civica recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica's affordable insulins, beginning in 2024, will benefit people...

The Opportunity The Associate Director, Senior Global Labeling Strategicst (Sr. GLS) acts as the principal labeling strategist within Global Regulatory Affairs. The Sr. GLE guides the creation and maintenance of the development Company Core Data Sheet (dCCDS), our Core Data Sheet (CCDS), the US Prescribing Information (USPI) and the EU Summary of Product Characteristics (SmPC) for CSL Behring's product portfolio, as assigned, to ensure understanding of the company position, labeling requirements, and commercial opportunities. As a expert, you will provide strategic input into the GRA Therapeutic Area Team from a labeling perspective. The Sr. GLE ensures that our company's core product claims across products with the same active substance are globally aligned and leads the Global Labeling Committee assessment of proposed changes to the dCCDS/CCDS, including management of the exception process between the CCDS and the USPI and EU SmPC. The Role Main Responsibilities...

University of Kentucky Equal Employment Opportunity/M/F/disability/protected veteran status. Posting Details Posting Details Job Title Assistant, Associate, or Professor in Medical Oncology Requisition Number FE03058 Working Title Department Name 7H367:INTERNAL MEDICINE & DIVISIONS-MED ONC Work Location Lexington, KY Type of Position Faculty Position Time Status Full-Time Tenure Track Status Non-Tenure Track Required Education MD or Equivalent Required Related Experience Completion of internal medicine residency and fellowship training in Medical Oncology and Hematology Required License/Registration/Certification Eligible for Kentucky medical licensure. Board certified in Internal Medicine/board eligible in Medical Oncology and Hematology Job Summary The University of Kentucky Markey Cancer Center and Department of Internal Medicine/Division of Medical Oncology/Hematologist is seeking a Board-Certified/Board...

University of Kentucky Equal Employment Opportunity/M/F/disability/protected veteran status. Posting Details Posting Details Job Title Assistant, Associate or Professor in Medical Oncology Requisition Number FE03059 Working Title Department Name 7H367:INTERNAL MEDICINE & DIVISIONS-MED ONC Work Location Lexington, KY Type of Position Faculty Position Time Status Full-Time Tenure Track Status Non-Tenure Track Required Education MD or Equivalent Required Related Experience Completion of internal medicine residency and fellowship training in Medical Oncology and Hematology Required License/Registration/Certification Eligible for Kentucky medical licensure. Board certified in Internal Medicine/board eligible in Medical Oncology and Hematology Job Summary The University of Kentucky Markey Cancer Center and Department of Internal Medicine/Division of Medical Oncology/Hematologist is seeking a Board-Certified/Board...

Newport Laboratories is seeking an experienced individual to join our team as a Quality Assurance Associate. Newport Labs, located in Worthington, Minnesota, is a leading provider of USDA autogenous vaccines and diagnostic services, and was recently acquired by Vaxxinova (more information below). About the Quality Assurance Associate Role: The Quality Assurance Associate, reporting to the Manager of Regulatory Affairs and Quality, is responsible for release functions within the Quality Assurance (QA) department. To assist and support the quality program, to ensure site wide compliance from isolation through production and testing, and the distribution of veterinary biologic products, within the guidelines set by regulatory agencies. Shift: Monday to Friday- between 7am and 5pm Main responsibilities of the Quality Assurance Associate: Readies production and batch record documentation and performs review for compliance to good documentation practices and against SOPs...

University of Kentucky Equal Employment Opportunity/M/F/disability/protected veteran status. Posting Details Posting Details Job Title Assistant, Associate, or Professor in Rheumatology Requisition Number FE03309 Working Title Rheumatology Clinical Physician Department Name 7H364:INTERNAL MEDICINE & DIVISIONS - RHEUMATO Work Location Lexington, KY Type of Position Faculty Position Time Status Full-Time Tenure Track Status Non-Tenure Track Required Education MD degree or equivalent Required Related Experience Residency and completion of fellowship training in Rheumatology Required License/Registration/Certification Ky Medical License within 30 days of appointment Job Summary The University of Kentucky is currently seeking a faculty member within the division of Rheumatology, in the College of Medicine. The search is being conducted at open rank, and this position will act as an attending physician for...

University of Kentucky Equal Employment Opportunity/M/F/disability/protected veteran status. Posting Details Posting Details Job Title Assistant, Associate, or Professor in Endocrinology Requisition Number FE02528 Working Title Department Name 7H357:INTERNAL MEDICINE & DIVISIONS - ENDOCRIN Work Location Lexington, KY Type of Position Faculty Position Time Status Full-Time Tenure Track Status Non-Tenure Track Required Education MD/DO degree or equivalent Required Related Experience Residency and completion of fellowship training in Endocrinology Required License/Registration/Certification Ky Medical License within 30 days of appointment Job Summary The University of Kentucky is seeking an open-rank faculty member in Internal Medicine that will act as an attending physician for Endocrinology Division. Duties include: Provide clinical care for patients while supervising residents in ambulatory and...

University of Kentucky Equal Employment Opportunity/M/F/disability/protected veteran status. Posting Details Posting Details Job Title Assistant, Associate, or Professor in Endocrinology Requisition Number FE02679 Working Title Department Name 7H357:INTERNAL MEDICINE & DIVISIONS - ENDOCRIN Work Location Lexington, KY Type of Position Faculty Position Time Status Full-Time Tenure Track Status Non-Tenure Track Required Education MD/DO degree or equivalent Required Related Experience Residency and completion of fellowship training in Endocrinology Required License/Registration/Certification Ky Medical License within 30 days of appointment Job Summary The University of Kentucky is seeking an open-rank faculty member in Internal Medicine that will act as an attending physician for Endocrinology Division. Duties include: *Provide clinical care for patients while supervising residents in ambulatory and...