Sr. Manager

6 days ago


Trenton, United States Atlas Search Full time

About the OpportunityOur client is a growing biopharmaceutical company in need of a Sr. Manager/Associate Director of Regulatory Affairs Strategy to join their team. This role is responsible for developing, implementing, and leading short/long term global regulatory strategies that support the success of their pharmaceutical products.The annual base salary range is $140,000 to $170,000. Actual compensation offered to the successful candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level, among other things. Details about eligibility for bonus compensation (if applicable) will be finalized at the time of offer.Job ResponsibilitiesServe as a liaison to FDA and provide strategic input with the regional regulatory leads responsible for ex-US regulatory activities. May provide oversight to regulatory consultants and vendors where applicableProvide regulatory strategic support and guidance across all functionsRoutinely perform regulatory precedence and competitive intelligence researchContribute to identification of potential issues/gaps and propose creative risk mitigation strategies to address gaps affecting optimal and timely submission and approvalAssess and communicate regulatory requirements to ensure development activities are in compliance with applicable regulations and guidelinesSupport and/or lead the planning and execution of global health authority interactions including support in generation and submission of briefing books, meeting preparationsAssist and/or lead in planning and execution of major and life-cycle management maintenance submissions and responses to regulatory authorities related to INDs, amendments, NDAs and supplements within company timelines and in accordance with regulations and guidelinesInterpret and communicate health authority correspondence effectively and quickly to senior leadership and project teamsJob RequirementsAdvanced degree (Masters, PharmD, PhD, MD) preferredExperience in Oncology/Rare Disease is preferred3+ years of regulatory experience within industry



  • Trenton, United States L3Harris Technologies Full time

    Job Title: Sr Spec, Program ManagementJob Code: 11990Job Location: Greenville, Texas Schedule: 9/80 Job Description:  The Program Manager Sr. Specialist is responsible for directing the daily tasks and ongoing administrative functions of the program initiatives adhering to contractual obligations and subsequent reporting on program initiatives from...


  • Trenton, United States Tris Pharma Full time

    Description Sr Project Manager, Operations for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc. Lead + manage proj plans detailing milestones, bdgt, resources, timing + roles + responsibilities for prgms incl scale-up activities, process validation, post-validation changes + comm w/ FDA. Provide tech spt to manufacturing + packaging ops or other...


  • Trenton, United States Tris Pharma Full time

    Description Sr Project Manager, Operations for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc. Lead + manage proj plans detailing milestones, bdgt, resources, timing + roles + responsibilities for prgms incl scale-up activities, process validation, post-validation changes + comm w/ FDA. Provide tech spt to manufacturing + packaging ops or other...


  • Trenton, United States SHI International Full time

    Job Summary: The Sr. ITAM Customer Success Manager (SR. CSM) is responsible for managing, expanding and renewing contracts with SHIs customers. The SR. CSM will help existing customers to maximize their investment in our ITAM programs. The position reports to the Manager ITAM Customer Success and ultimately to the Director of ITAM Customer Success. The SR....


  • Trenton, United States SHI International Full time

    Job Summary The Sr. ITAM Customer Success Manager (SR. CSM) is responsible for managing, expanding and renewing contracts with SHI’s customers. The SR. CSM will help existing customers to maximize their investment in our ITAM programs. The position reports to the Manager – ITAM Customer Success and ultimately to the Director of ITAM Customer Success. The...


  • Trenton, New Jersey, United States SHI International Full time

    Job Summary:The Sr. ITAM Customer Success Manager (SR. CSM) is responsible for managing, expanding and renewing contracts with SHIs customers. The SR. CSM will help existing customers to maximize their investment in our ITAM programs. The position reports to the Manager ITAM Customer Success and ultimately to the Director of ITAM Customer Success.The SR. CSM...

  • Sr. Product Manager

    2 weeks ago


    Trenton, United States Terumo Cardiovascular Group Full time

    Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers...


  • Trenton, New Jersey, United States Terumo Cardiovascular Group Full time

    Press Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert:Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with...


  • Trenton, United States Elevance Health Full time

    Account Service Manager Sr Location: This position will work in a hybrid model (remote and office). The ideal candidate must live within 50 miles of one of our Elevance Health Pulse Point locations listed on the requisition. The Account Service Manager Sr is responsible for providing highly advanced account management representation and strategic planning...


  • Trenton, United States Daiichi Sankyo Company, Limited Full time

    Sr Director, Global Project Management & Leadership page is loaded Sr Director, Global Project Management & Leadership Apply remote type Hybrid Work Arrangement locations Basking Ridge, NJ time type Full time posted on Posted 2 Days Ago job requisition id R3388 Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the...


  • Trenton, United States Robert Half Full time

    Our client, a leading and dynamic agency within the marketing, digital advertising, and PR sphere, is seeking a seasoned Public Relations Sr. Account Manager.As a Sr. Account Manager, you are a PR expert, a versatile professional, and a natural leader with a demonstrated ability to deliver impressive results for clients. You stay ahead of trends in the PR...


  • Trenton, United States Robert Half Full time

    Our client, a leading and dynamic agency within the marketing, digital advertising, and PR sphere, is seeking a seasoned Public Relations Sr. Account Manager.As a Sr. Account Manager, you are a PR expert, a versatile professional, and a natural leader with a demonstrated ability to deliver impressive results for clients. You stay ahead of trends in the PR...


  • Trenton, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...


  • Trenton, United States Molson Coors Full time

    Requisition ID: 30904 A Career in Beer and Beyond: Our purpose at Molson Coors Beverage Company is to brew beverages that unite people to celebrate all life's moments. We've been brewing iconic brands for over 350 years and are now proud to be offering a modern portfolio that expands beyond the beer aisle. We are Talent Brewers with our culture rooted in...


  • Trenton, New Jersey, United States Pacer Staffing Full time

    Job Title: Sr. QA Manager Duration: 06 months Location: Foster City, CA Shift Hours: Monday – Friday (Hybrid) Primary Responsibilities Lead and facilitate Quality Event Investigations and subsequent CAPA development in accordance with defined timelines and in collaboration with appropriate subject matter experts.Build, deploy and reinforce learning tools...


  • Trenton, United States International Flavors and Fragrances Full time

    Job Description The Sr. Manager Cellulose & Pulp) will be responsible for developing and communicating procurement strategies that support the business goals in growth, cost savings, risk mitigation, working capital improvement, development of new products and achievement plant operating efficiencies. The portfolio will include the following products :...


  • Trenton, United States International Flavors and Fragrances Full time

    Job Description The Sr. Manager Cellulose & Pulp) will be responsible for developing and communicating procurement strategies that support the business goals in growth, cost savings, risk mitigation, working capital improvement, development of new products and achievement plant operating efficiencies. The portfolio will include the following products :...


  • Trenton, United States Mars (New) Full time

    Sr Tax Manager- Mergers & Acquisitions page is loaded Sr Tax Manager- Mergers & Acquisitions Apply remote type Hybrid locations USA-Illinois-Chicago USA-New Jersey-Hackettstown time type Full time posted on Posted 2 Days Ago job requisition id R101758 Job Description: The Tax Manager – Mergers and Acquisitions is responsible for driving tax strategy and...


  • Trenton, New Jersey, United States Kenvue Inc Full time

    Come work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation.Job Description - Sr Manager Finance Compliance, SOX W)Sr Manager Finance Compliance, SOX WDescriptionKenvue is currently recruiting for:Finance Compliance, Global Lead SOX Coordination(PG 31)This position reports into Global Director Finance...


  • Trenton, New Jersey, United States PS&S Full time

    Overview PS&S is an award winning "one-stop shop" of architecture and engineering excellence, which was established in 1962. The depth and breadth of our expertise has helped PS&S grow into a firm offering multi-disciplined, full-service architecture, engineering, design, environmental and surveying consulting services.Position Summary The Sr. Geotechnical...