Global Regulatory CMC Manager

Found in: beBee S US - 2 weeks ago


Summit, United States Axelon Services Corporation Full time
  • 5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience.
  • Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
  • These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.
  • Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
  • Responsible for the global regulatory evaluation of CMC change controls with supervision.
  • Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams.
  • Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents)
  • Experience in developing CMC regulatory strategy


  • Summit, United States Insight Global Full time

    Insight Global is looking for a Sr. Contract Analyst to join one of our large pharmaceutical clients in Berkeley Heights, NJ. The Sr. Contract Analyst serves as an integral contributor working cross functionally in the Contract Lifecycle Management team with responsibility for negotiating contract terms, drafting offer letters, executing, and implementing...

  • Scientist/Engineer

    2 weeks ago


    Summit, United States Axelon Services Corporation Full time

    Job Description: The Scientist/Engineer is responsible for leading manufacturing and QC investigation reports in support of S12 CAR T operations. This includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive...

  • Scientist/Engineer

    6 days ago


    Summit, United States Axelon Services Corporation Full time

    Job Description: The Scientist/Engineer is responsible for leading manufacturing and QC investigation reports in support of S12 CAR T operations. This includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive...

  • Surgical Tech

    5 days ago


    Summit, United States Insight Global Full time

    Job DescriptionJob DescriptionSkillset: Surgical TechniciansLocation: Summit, NJShift: 11 overnight- 7pm-7am8 day/evening- 7am-5pm or 7-7pmDuration: 3-month contract-to-hirePay Rate : Based on experience 0-2 years= $35/hour is the starting pointStart Date: May 6thInsight Global is looking for skilled Surgical Techs to sit our large healthcare client in NJ....

  • Director, Industrial Hygiene, Safety CoE

    Found in: beBee S US - 1 week ago


    Summit, United States Bristol Myers Squibb Full time

    From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.The Director of Industrial Hygiene will be responsible for leading the development and implementation of global industrial hygiene programs and policies across BMS through the Safety CoE. This...

  • Sr Quality Assurance Specialist

    Found in: Appcast US C2 - 2 days ago


    Summit, United States Integrated Resources, Inc ( IRI ) Full time

    The Scientist/Engineer is responsible for leading manufacturing and QC investigation reports in support of S12 CAR T operations. This includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive actions (CAPA), and...

  • Sr Quality Assurance Specialist

    Found in: Appcast Linkedin GBL C2 - 2 days ago


    Summit, United States Integrated Resources, Inc ( IRI ) Full time

    The Scientist/Engineer is responsible for leading manufacturing and QC investigation reports in support of S12 CAR T operations. This includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive actions (CAPA), and...

  • Investigations Specialist

    Found in: Appcast Linkedin GBL C2 - 4 days ago


    Summit, United States Integrated Resources, Inc ( IRI ) Full time

    Job Description: The Scientist/Engineer is responsible for leading manufacturing and QC investigation reports in support of S12 CAR T operations. This includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive...


  • Summit, United States Integrated Resources, Inc ( IRI ) Full time

    Job Description: The Scientist/Engineer is responsible for leading manufacturing and QC investigation reports in support of S12 CAR T operations. This includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive...


  • Summit, United States Piper Companies Full time

    Piper Companies is currently seeking a QA Document Control Associate for an opportunity in Summit, New Jersey (NJ), to join a global biopharmaceutical company delivering life-saving medicines to patients with serious diseases. Responsibilities of the QA Document Control Associate Manage electronic document system, including document change control and...


  • Summit, United States Bristol-Myers Squibb Full time

    Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Practice Manager I

    2 weeks ago


    Summit, United States Atlantic Health System Full time

    Job Description Responsible for comprehensive administrative support and direction to an AHS physician practice, overseeing day-to-day services and contributing to an environment of clinical excellence Principal Accountabilities: 1. Ensures compliance with all appropriate regulatory agencies, corporate compliance, system protocols and office procedures and...


  • Summit, United States CareerBuilder Full time

    STRATEGIC STAFFING SOLUTIONS HAS AN OPENING! This is a Contract Opportunity with our company that MUST be worked on a W2 Only. No C2C eligibility for this position . Role Title: Backend Java Developer Locations: Summit, NJ; Chandler, AZ; Minneapolis, MN; Charlotte, NC (Hybrid On-Site and Some Remote) Duration: 9+ Months Role Type: W2 Contract Engagement...


  • Summit, United States Katalyst HealthCares & Life Sciences Full time

    Responsibilities: Responsible for providing quality oversight for the qualification and validation activities for equipment, utilities, and facilities. This role will be responsible for drafting, reviewing and approving qualification protocols/reports and any associated documentation in support of CQV activities for a new facility. The Role also needs to...


  • Summit, United States CareerBuilder Full time

    The Opportunity: The Associate Director, Strategic Pricing will have a broad range of responsibilities related to revenue management, pricing strategy, and the development of pricing tools. You will have a comprehensive understanding of revenue management, a thorough awareness of diverse pricing strategies, and the ability to develop appropriate tools to...


  • Summit, United States CSL Seqirus Full time

    The Opportunity: The Associate Director, Strategic Pricing will have a broad range of responsibilities related to revenue management, pricing strategy, and the development of pricing tools. You will have a comprehensive understanding of revenue management, a thorough awareness of diverse pricing strategies, and the ability to develop appropriate tools to...

  • Associate Director, Strategic Pricing

    Found in: beBee S US - 3 weeks ago


    Summit, United States CSL Behring Full time

    The Opportunity:The Associate Director, Strategic Pricing will have a broad range of responsibilities related to revenue management, pricing strategy, and the development of pricing tools.You will have a comprehensive understanding of revenue management, a thorough awareness of diverse pricing strategies, and the ability to develop appropriate tools to...

  • Care Manager

    4 days ago


    Summit, United States VNS Health Full time

    OverviewConducts assessments and develops client/member centered plans of care. Provides coordination of services between the varying providers for clients / members with complex psychiatric, substance use, and/or co-morbid medical conditions. Ensures access and linkage to the full array of necessary physical and behavioral health services and other...

  • Care Manager

    4 days ago


    Summit, United States VNS Health Full time

    Overview Conducts assessments and develops client/member centered plans of care. Provides coordination of services between the varying providers for clients / members with complex psychiatric, substance use, and/or co-morbid medical conditions. Ensures access and linkage to the full array of necessary physical and behavioral health services and other...

  • Stroke Program Manager

    Found in: Talent US C2 - 2 weeks ago


    Summit, United States Atlantic Health (SP) Full time

    Details Salary: Open Categories: General Nursing Required Education: High School Internal Number: Overview Atlantic Health System is seeking a full-time Stroke Program Manager at Overlook Medical Center. Responsibilities Essential Functions/Responsibilities of Position: Clinical Responsibilities: * Acts as an expert resource clinical...