/JOB PURPOSE The Associate Regulatory Operations Director is responsible for overseeing submission activity for the company's submission portfolio, with first line accountability for managing the submission forecast and ensuring proper staffing for upcoming submissions. She/he utilizes in depth knowledge of global regulatory submission requirements and works collaborativel

The Senior Manager, Regulatory Information Management (RIM), will work closely with R&D and Manufacturing well as other functions within Jazz, to manage training, documentation, user experience, and maintenance of the RIM system and integration with the other systems at Jazz Essential Functions Understand the business processes (across R&D and Manufacturing), regulatory a

Manage all aspects of submissions relevant to assigned projects and programs, in accordance with submission and regulatory requirements. Lead cross functional groups across the organization in the development of global regulatory strategy to complete developmental and post approval regulatory submissions. Define contributions for submissions, communicate to functional con

Braun Medical Inc. ("B.Braun") has an opening for a Senior Counsel, Life Science Regulatory and Quality. The Senior Counsel, Life Science Regulatory and Quality, will support a wide variety of global regulatory and quality matters related to the design, manufacture, distribution and sale of medical devices and pharmaceuticals throughout the world, including product submis

Benefits At Vibra Healthcare, employees are our priority. We are passionate about patient care and consider it a privilege to be able to provide services to patients and their family members. Below is a brief summary of our benefits. Medical PPO high and low deductible plans / HSA options as well as HMO options in some markets FREE prescription plans Dental and Vision cov

Site Name USA Maryland Rockville, Cambridge Binney Street, Durham Blackwell Street, USA Pennsylvania Upper Providence Posted Date May 22 2024 At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent an

Senior Regulatory Affairs Associate Experience Biologic CMC 5+ years of experience Supported the CMC activities related to Vaccine/Biologic manufacturing and control including authoring of submission dossiers related to new application, post approval variations Understanding of EU/CA/WHO/US regulations & guidance allowing appropriate review and compilation of data to appr

/JOB PURPOSE Responsible for managing and maintaining existing investigational new drug (IND) and clinical trial application (CTA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications to regulatory agencies. Essential Duties And Responsibilities Review clinical site regulatory documents t

Viatris Specialty LLC At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via Access Providing high quality trusted medicines regardless of geography or circumst

Duties WHAT IS THE SMALL BUSINESS SELF EMPLOYED DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas SBSE Small Business/Self Employed, SB/SE Deputy Commissioner Exam, Specialty Examination, Estate & Gift /Excise Tax Exam The following are the duties of this position at the full working level. If this vaca

The Attorney IV Regulatory Law will handle a variety of regulatory legal matters, including representing Duquesne Light in formal proceedings at the Federal Energy Regulatory Commission (FERC) and Pennsylvania Public Utility Commission (PA PUC), as well as providing comprehensive client counseling and strategic support on utility regulatory issues. Key Responsibilities Wo

Pharma and Personal Care Regulatory Affairs Manager/ NA Regulatory Business Partner At Ecolab, making the world a cleaner, safer place is our business. In our Pharmaceutical & Personal Care (PPC) division, we are committed to providing complete solutions for the Pharma & Personal Care Industries. Ecolab is a company committed to growth and we believe that the role of Regu

Site Name USA Maryland Rockville, USA Pennsylvania Upper Providence Posted Date Apr 11 2024 Are you looking for a regulatory leadership role where you can build advocacy and accelerate product development and licensure on a global scale, but with a focus on US? If so, this Director, Global Regulatory Affairs, Vaccines role could be an exciting opportunity to explore. As a

Duties WHAT IS THE LARGE BUSINESS AND INTERNATIONAL (LBI) DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas Large Business and International Director Northeastern Compliance Practice Area (NECPA) The following are the duties of this position at the full working level. If this vacancy includes more than

Site Name USA Maryland Rockville, USA Pennsylvania Upper Providence Posted Date Apr 30 2024 Are you looking for a highly visible role where you can ensure the development and execution of appropriate strategies across all stages of the product life cycle consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP)? If so, this role could be an exciting op