Regulatory Associate Chemistry

hace 13 horas


Xico, México Pfizer A tiempo completo
Why Patients Need You

We're committed to bringing medicines to the world faster, without compromising on excellence and integrity. Adhering to local and global regulations is essential, and our team requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will Achieve

  • You will assist CMC professionals with the development of CMC regulatory strategies, submissions, and compliance activities for biopharmaceutical development programs and commercial products supporting the Global Pfizer Biopharmaceuticals Group Hospital and Global Brands CMC portfolio.
  • Provide operational global CMC regulatory support and documentation for assigned projects/products covering clinical development, initial registrations, and approval/post approval activities of low to medium complexity/risk.
  • Support the assembly of CMC information for submission to global regulatory agencies and supports CMC strategies with supervision.
  • Maintain and track submission and approval status.
  • Assist in regulatory fact finding for the preparation of CMC information for submission to global regulatory agencies.
  • Maintain CMC systems and perform data entry.
  • Assist cross-functional project teams by scheduling meetings, taking meeting notes, and tracking action items independently.

How You Will Achieve It

  • Manages projects, makes decisions, and executes upon strategies and plans with minimal oversight from manager.
  • Recommends solutions and escalates issues with significant business impact where necessary.
  • Supports team in the development of regulatory strategies to support registrations.
  • Demonstrates a high level of integrity in decision making on regulatory issues in line with company values.
  • Responsible to assist in the authoring of CMC documentation, coordination, and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance, and management of change control of moderate complexity with appropriate supervision.
  • Fosters a culture in which uncompromising integrity and accountability is the standard.
  • Makes decisions to resolve low to moderately complex problems in standard situations.
  • Makes decisions within guidelines and policies and with appropriate consultation with the Team Leader.
  • Ability to collaborate effectively across a network of other stakeholders, partners, and customers, to compile high-quality CMC inputs and aiding the compliance of the Pfizer essential biopharmaceutical product portfolio.
  • Assists in the development of resolution proposals for low to moderate regulatory CMC/information management issues in support of project/program stakeholders.
  • Displays a willingness to make appropriate and timely decisions, exhibits sound and accurate judgment.
  • Ability to develop project plans to support short-term operational goals and contribute to the development of global regulatory initiatives with appropriate supervision.

Basic Qualifications

  • Must-Have: BS/MS/PhD or equivalent scientific/engineering/pharmaceutical development sciences degree.
  • Minimum 3 years' work experience required.
  • Basic understanding of manufacturing/pharmaceutical sciences/the pharmaceutical industry with an understanding of drug development/commercial manufacturing of pharmaceutical products with technical writing skills.
  • Competent working knowledge of computer-based systems such as Microsoft Office, controlled documentation systems (e.g. Documentum).
  • Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willingness to support others in system use.

EEO (Equal Employment Opportunity) & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.


  • Laboratory Technician

    hace 4 semanas


    Xico, México Oilandgas.Org A tiempo completo

    Job SummaryWe are seeking a highly motivated and detail-oriented Laboratory Technician - Chemistry Associate to join our team at Oilandgas.Org. As a key member of our laboratory team, you will be responsible for conducting laboratory tests and experiments, maintaining accurate records, and ensuring compliance with safety protocols.Key...

  • Regulatory Data Associate

    hace 4 semanas


    Xico, México Pfizer A tiempo completo

    Job SummaryThis role will work within a team whose main focus will be to interpret the regulatory data received across different geographies, functions, divisions and ensuring key activities and regulatory systems updates are completed whilst adhering to all policies, practices and procedures.Key Responsibilities:Review and interpret the data provided by the...


  • Xico, México Amgen Sa A tiempo completo

    Job SummaryAmgen Sa is seeking a highly skilled Regulatory Affairs Senior Associate to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring the timely and compliant submission of regulatory documents for our products in Mexico.Key ResponsibilitiesDevelop and execute the filing plan for Mexico,...


  • Xico, México Amgen A tiempo completo

    {"title": "Senior Associate Regulatory Affairs", "description": "Unlock Your Potential in Regulatory AffairsAt Amgen, we're driven by a shared mission to serve patients. As a Senior Associate Regulatory Affairs professional, you'll play a critical role in ensuring our regulatory submissions meet the highest standards. Your expertise will help us navigate the...


  • Xico, México Solventum A tiempo completo

    {"title": "Regulatory Affairs Specialist", "content": "**Job Summary**:Solventum is seeking a highly skilled Regulatory Affairs Specialist to join our team in Mexico City. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements for medical devices in Mexico.**Key...


  • Xico, México Takeda Pharmaceutical A tiempo completo

    **Job Summary**Takeda Pharmaceutical is seeking a highly skilled Regulatory Affairs Specialist to join our team in Mexico City, Mexico. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring compliance with regulatory requirements and developing strategies to drive business growth.**Key Responsibilities**Collaborate...


  • Xico, México Gsk A tiempo completo

    Regulatory Affairs DirectorYour Responsibilities:Develop and execute strategic plans for obtaining regulatory approvals for Vaccines, Pharmaceutical, and ViiV pipeline products.Lead lifecycle management of Marketing Authorizations, including license variations and renewals, to ensure supply continuity and updated product labeling.Provide regulatory support...


  • Xico, México Solventum A tiempo completo

    Job SummarySolventum is seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with regulatory requirements for our medical devices.Key ResponsibilitiesReview and support business-related to marketing and advertising for healthcare...


  • Xico, México Icon A tiempo completo

    Study Start Up AssociateAt ICON, we are committed to advancing clinical research and improving patient outcomes. As a Study Start Up Associate, you will play a critical role in ensuring the successful initiation of clinical trials.Key Responsibilities:Review and negotiate clinical site investigator contracts and budgetsMaintain communication with...


  • Xico, México Bayer A tiempo completo

    {"h1": "Regulatory Affairs Specialist", "p": "At Bayer, we are seeking a highly skilled Regulatory Affairs Specialist to join our team in Mexico City. As a key member of our Regulatory Affairs team, you will be responsible for ensuring the compliance of our medical devices with local regulations in the LATAM region.Your key responsibilities will include:*...


  • Xico, México Pfizer A tiempo completo

    Why Patients Need YouWe're committed to bringing medicines to the world faster, without compromising on excellence and integrity. Adhering to local and global regulations is essential, and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to...


  • Xico, México Icon A tiempo completo

    Job SummaryWe are seeking a highly skilled Study Start Up Associate II to join our team at ICON. As a Study Start Up Associate II, you will be responsible for collecting, preparing, reviewing, approving, processing, and tracking regulatory and site-level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs,...


  • Xico, México Thermo Fisher Scientific A tiempo completo

    {"Job Title": "Clinical Research Associate", "Job Summary": "We are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team at Thermo Fisher Scientific. As a Clinical Research Associate, you will be responsible for conducting clinical trials in a clinical environment, providing medical research support, and ensuring...


  • Xico, México Abbvie A tiempo completo

    Clinical Research Associate Job DescriptionAt AbbVie, we are seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will play a critical role in ensuring the successful execution of clinical studies at investigative sites.Key Responsibilities:Conduct site qualification, initiation, interim monitoring, and...


  • Xico, México Novasyte A tiempo completo

    {"Job Overview": "At Novasyte, we are seeking a skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for performing site monitoring visits, administering protocol and related study training, and evaluating the quality and integrity of study site practices.", "Responsibilities": "Key responsibilities...

  • Site Management Associate

    hace 4 semanas


    Xico, México Icon Plc A tiempo completo

    About the RoleWe are seeking a highly skilled Site Management Associate to join our team at ICON plc, a world-leading healthcare intelligence and clinical research organization. As a Site Management Associate, you will play a critical role in managing, implementing, and monitoring clinical studies, ensuring compliance with ICON SOPs, SSPs, and all applicable...


  • Xico, México Iqvia A tiempo completo

    Job OverviewWe are seeking a highly organized and detail-oriented Clinical Trial Associate to join our team. As a Clinical Trial Associate, you will play a critical role in ensuring the successful execution of clinical trials.Key ResponsibilitiesAssist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and...


  • Xico, México Psi Cro A tiempo completo

    Job SummaryAt PSI, we are seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will play a critical role in the success of our clinical studies by conducting and reporting onsite monitoring visits, performing CRF review, source document verification, and query resolution.Key ResponsibilitiesConduct and...


  • Xico, México Psi Cro Ag A tiempo completo

    About Psi Cro AgPsi Cro Ag is a leading Contract Research Organization with a rich history of delivering high-quality services across various therapeutic indications. Our organization prides itself on striking a perfect balance between stability and innovation, providing a dynamic work environment for our employees and clients alike.Job SummaryWe are seeking...


  • Xico, México Novasyte A tiempo completo

    {"Job Overview": "At Novasyte, we are seeking a skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for ensuring the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.", "Key Responsibilities": "Perform site monitoring...