Empleos actuales relacionados con Regulatory Senior Associate Chemistry - Tlahuac - Pfizer

  • Specialist - Chemistry & Toxicology

    hace 8 meses

    Tlahuac, México UPL ltd A tiempo completo

    **Specialist - Chemistry & Toxicology**: - Job Id: 9028- City: Mexico City, Distrito Federal, Mexico- Department: Regulatory- Function: Regulatory, Research and Development- Employee Type: Permanent Full Time- Seniority Level: Mid-Senior level- Description: - Asegurar el cumplimiento administrativo regulatorio de productos de protección de cultivos y...

  • Regulatory Affairs Associate Consultant

    hace 7 meses

    Tlahuac, México ClinChoice A tiempo completo

    Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds. ClinChoice is searching for a **Regulatory Affairs Associate Consultant** to join one of our clients. **Main Job Tasks and Responsibilities**: -...

  • Regulatory Affairs Specialist

    hace 7 meses

    Tlahuac, México Bayer A tiempo completo

    **Regulatory Affairs Specialist** **Position purpose** Act as LRA (Local RA) for all the daily activities that will ensure registrations of Radiology Medical Devices are properly done in LATAM region by submitting local dossiers, keeping country requirement table and SharePoint site folder structure updated, and ensuring the proper trackers are up to...

  • Regulatory Engagement Lead

    hace 7 meses

    Tlahuac, México Citi A tiempo completo

    **Responsibilities**: - Responsible for providing risk strategic analytics, information management across Citibank products and reports to senior management. - Responsible for communicating to executive management implications of existing and opposed regulation and developing potential responses. This may include regulations related to specific product or...

  • Regulatory Policy Manager

    hace 2 semanas

    Tlahuac, México HSBC A tiempo completo

    **Regulatory Policy Manager** **Role Purpose. **Global Regulatory Policy (‘GRP’) is responsible for establishing HSBC’s Group level, and certain regional level, regulatory capital policies, and for advising the firm’s business lines of the impact of these policies upon transactions and new products. **Main activities**: Track new policy...

  • Latam & Mexico Regulatory Exam Management &

    hace 8 meses

    Tlahuac, México Citi A tiempo completo

    Serves as a risk officer for Independent Compliance Risk Management (ICRM)’s Exam Management and Regulatory Liaison Office responsible for the promotion, support, monitoring and reporting on Citi’s interactions with its regulators, including queries arising in the normal course of business outside of specific examinations, and managing supervisory...

  • Regulatory Affairs Specialist

    hace 7 meses

    Tlahuac, México Edwards Lifesciences A tiempo completo

    Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail...

  • Sr Associate Regulatory Affairs

    hace 7 meses

    Tlahuac, México Amgen A tiempo completo

    **HOW MIGHT YOU DEFY IMAGINATION?**: If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering...

  • Regulatory Affairs Associate Consultant-plm

    hace 2 días

    Tlahuac, México ClinChoice A tiempo completo

    Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds. ClinChoice is searching for a **Regulatory Affairs Associate Consultant** to join one of our clients. **Main Job Tasks and Responsibilities**: -...

  • Senior Associate, Site Operations

    hace 7 meses

    Tlahuac, México Capital One A tiempo completo

    WeWork Reforma Latino (97001), Mexico, Ciudad de Mexico, Ciudad de Mexico Senior Associate, Site Operations At Capital One, we dare to dream, disrupt and deliver a better way. Our goal is simple—bring ingenuity, simplicity and humanity to an industry ripe for change. In Global Workplace Services (GWS), we deliver holistic solutions that serve and...

  • Regulatory Advisor

    hace 7 meses

    Tlahuac, México Citi A tiempo completo

    **Responsibilities**: - Ensure accurate and timely delivery of key changes to the business by leading Global Change Management (GCM) process - Creating and managing end to end calendar with critical steps, dependencies and dates - Hosting kick-off calls with change owner to gather stakeholders, begin impact assessment and identify leads from each functional...

  • Business Office Regulatory Reports

    hace 7 meses

    Tlahuac, México Citi A tiempo completo

    **Responsibilities**: - Coordinate key regulatory interactions (formal examinations, on-going supervisions, ad-hoc regulatory deliverables) that span across geographies (Local and Citi levels), businesses, products, support and control functions. - Ensure adherence to regulatory governance standards to promote consistency of processes across the...

  • Senior Associate, Employee Services, Us

    hace 9 meses

    Tlahuac, México Warner Bros Careers A tiempo completo

    **_Every great story has a new beginning, and yours starts here._** **_ Welcome to Warner Bros. Discoverythe stuff dreams are made of._** **Who We Are ** When we say, “the stuff dreams are made of,” we’re not just referring to the world of wizards, dragons and superheroes, or even to the wonders of Planet Earth. Behind WBD’s vast portfolio of...

  • Business Manager

    hace 2 semanas

    Tlahuac, México HSBC A tiempo completo

    **Business Manager - Regulatory Reports** **Principal Function**: Business Administration & Operational Management will participate in business activities, supporting Senior Managers with BAU & non-BAU activities, cyclical work pieces such as Daily, Monthy, Quarter Annual Regulatory Reporting and short term initiatives. They are located in BAU teams and...

  • Senior Associate, Adaptation

    hace 9 meses

    Tlahuac, México Global Green Growth Institute A tiempo completo

    **The Adaptation & Climate Change Senior Associate will be part of the GGGI Mexico team based in Mexico City. S/he will work in close collaboration with other staff in CAID, IPSD, and other GGGI divisions, particularly Mexico’s country team and under the guidance of the Mexico’s Country Representative.** **The Senior Associate is expected to be a...

  • Associate, Sustainability Consulting

    hace 7 meses

    Tlahuac, México ELEVATE A tiempo completo

    **Associate JD LATAM** **Role** Associate, Sustainability Consulting, LATAM (Responsible Sourcing, Supply Chain, Human Rights and Business) **Location** Monterrey, Mexico **Who we are** ELEVATE is an industry leader in sustainability and supply chain services globally, with more than 17 years’ expertise in designing, building and managing...

  • Regulatory & Compliance Operational Risk Manager

    hace 8 meses

    Tlahuac, México Citi A tiempo completo

    **Responsibilities**: - Contributes to risk assessments and drives actions to address the root causes that persistently lead to operational risk losses by challenging both historical and proposed practices. - Provides governance and oversight may include (not limited to) technology operational risk, risk for example. - Evaluates the control environment by...

  • Sr Business Associate

    hace 7 meses

    Tlahuac, México Citi A tiempo completo

    The Business Associate is a senior level position responsible for the overall administrative activities of a business. These tasks may include managing external audits, business continuity activities or addressing regulatory issues. The Business Associate may coordinate and manage activities such as the tracking of business financials, employee headcount and...

  • Regulatory Conduct Capabilities

    hace 9 meses

    Tlahuac, México HSBC A tiempo completo

    -Job description Role Purpose The HSBC Mexico Risk Control Oversight Office is a special unit operating under the Office of the Mexico CEO with a Board mandate to provide comprehensive assessment and monitoring of all regulatory programs across HSBC Mexico, coordination and acceleration of existing remediation or risk mitigation efforts across all Mexico...

  • Regulatory Reporting Manager

    hace 7 meses

    Tlahuac, México Citi A tiempo completo

    **Responsibilities**: - Manage and drive the incident management process from Start to Finish. - Produce the weekly Incident Management Report communicated with all senior leaders in supported Lines of Business. - Facilitates and ensures Issue Management Quality Standards are met for issues documented - Act as the Single point of Contact for issue...

Regulatory Senior Associate Chemistry

hace 7 meses

Tlahuac, México Pfizer A tiempo completo

Why Patients Need You

We're looking to bring medicines to the world faster and we are not willing to compromise 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 Pfizer medicines and vaccines.

What You Will Achieve- You will assist chemistry, manufacturing, and control (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, with supervision.- 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 mínimal 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 projects 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.Nice to Have- Basic experience in CMC supporting clinical and post approval programs with diverse dosage forms is desirable.- Drug substance or drug product development or manufacturing technical support experience.

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.

Regulatory Affairs

LI-PFE