Jobs
>
Tarrytown

    CMC Regulatory Affairs Manager - Tarrytown, United States - Katalyst HealthCares & Life Sciences

    Katalyst HealthCares & Life Sciences
    Katalyst HealthCares & Life Sciences Tarrytown, United States

    1 week ago

    Default job background
    Description
    Responsibilities:
    • Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities, ensuring accuracy, completeness, and compliance with applicable regulations and guidelines.
    • Provide regulatory guidance and support to cross-functional teams throughout the product development lifecycle, including manufacturing process development, technology transfer, scale-up, validation, and post-approval changes.
    • Interpret and communicate regulatory requirements, guidelines, and expectations related to CMC to internal stakeholders, ensuring alignment with global regulatory strategies and objectives.
    • Proactively identify regulatory risks, opportunities, and challenges related to CMC activities and provide strategic recommendations to mitigate risks and optimize regulatory outcomes.
    • Collaborate with internal stakeholders, including Manufacturing, Quality Assurance, Quality Control, Supply Chain, and Clinical Development, to ensure regulatory compliance and alignment with business objectives.
    • Establish and maintain positive relationships with regulatory agencies and industry peers, representing the company in regulatory interactions, meetings, and negotiations as needed.
    • Stay abreast of emerging regulatory trends, changes, and developments related to CMC and communicate potential impacts to relevant stakeholders.

    Requirements:

    • Bachelor's, Master's, or Ph.D. degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related scientific discipline.
    • 5-7 years of experience in regulatory affairs CMC in the pharmaceutical industry.
    • Demonstrated expertise in preparing CMC sections of regulatory submissions (e.g., INDs, NDAs, BLAs, MAAs, IMPDs) and interacting with global health authorities (e.g., FDA, EMA, Health Canada, PMDA).
    • Strong understanding of global regulatory requirements, guidelines, and expectations related to CMC for pharmaceutical products (e.g., ICH guidelines, FDA regulations, EudraLex).
    • Excellent communication, collaboration, and project management skills, with the ability to effectively interact with cross-functional teams and external stakeholders.
    • Proven ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines in a fast-paced, dynamic environment.
    • Detail-oriented mindset with a focus on quality, accuracy, and compliance.
    • Experience with regulatory submissions for small molecules, biologics, or other pharmaceutical modalities is preferred.
    • Regulatory Affairs Certification (RAC) is a plus.
  • PXP

    Business Affairs Manager

    3 weeks ago

    PXP New York, United States

    **Company Description** · PXP is Publicis Groupe's future-facing global content and production network, fully immersed in the realm of data, the technological revolution, and the platform-driven world. We craft and deliver impactful consumer experiences using cutting-edge creativ ...

  • New York University

    Faculty Affairs Manager

    3 weeks ago

    New York University New York, United States

    Position Summary: · Manage the ongoing Faculty Affairs activities for the full-time faculty population of the Steinhardt School of Culture, Education, and Human Development. Manage faculty lifecycle milestones including onboarding, offboarding, reviews, and special Faculty Affair ...

  • Madwell

    Business Affairs Manager

    3 weeks ago

    Madwell Brooklyn, United States

    **Business Affairs Manager** · **Who We Are** · Madwell is a Brooklyn-based creative collective built to disrupt the traditional agency model. Why? Because we believe successful marketing can be anything. And we love that. We were founded in 2010 in Bushwick, Brooklyn and still c ...

  • Con Edison Company of New York

    Corporate Affairs Manager

    3 weeks ago

    Con Edison Company of New York New York, United States

    **Mission Statement** · - Consolidated Edison Company of New York, Inc. (Con Edison), Orange & Rockland Utilities (O&R), and Consolidated Edison Transmission (CET) employees are required to follow health, safety, and environmental policies, EEO, Standards of Business Conduct, and ...

  • Regeneron Pharmaceuticals, Inc.

    Manager, Regulatory Affairs

    1 week ago

    Regeneron Pharmaceuticals, Inc. Tarrytown, United States Full time

    The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the p ...

  • Meta

    Public Affairs Marketing Manager

    3 weeks ago

    Meta New York, United States

    We believe in the endless power of people when they come together. But we also believe strongly in our responsibility to minimize harm and keep people safe. In this role, you will be responsible for executing global and domestic Public Affairs marketing campaigns around high-prio ...

  • AstraZeneca

    Medical Affairs Manager

    1 week ago

    AstraZeneca New York, United States

    Medical Affairs Manager - Lungenkrebs Pipeline · Standort: Wien · AstraZeneca ist eines der weltweit führenden biopharmazeutischen Unternehmen, welches sich auf die Entdeckung, Entwicklung undVermarktungverschreibungspflichtigerArzneimittelkonzentriert. Weltweit profitieren Milli ...

  • Katalyst HealthCares & Life Sciences

    Regulatory Affairs Senior Manager

    1 week ago

    Katalyst HealthCares & Life Sciences Tarrytown, United States

    Responsibilities: US Agent for all products, responsible for communication between the FDA and manufacturing sites. · Communicate and follow-up status with FDA for any Chemistry, Bioequivalence and Patents issues and correspondences on both pending and approved applications. · ...

  • Regeneron Pharmaceuticals, Inc.

    Senior Manager, Regulatory Affairs

    1 week ago

    Regeneron Pharmaceuticals, Inc. Tarrytown, United States Full time

    The Sr. Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and t ...

  • Katalyst HealthCares & Life Sciences

    Regulatory Affairs Senior Manager

    1 week ago

    Katalyst HealthCares & Life Sciences Tarrytown, United States

    Responsibilities: US Agent for all products, responsible for communication between the FDA and manufacturing sites. · Communicate and follow-up status with FDA for any Chemistry, Bioequivalence and Patents issues and correspondences on both pending and approved applications. · ...

  • Regeneron Pharmaceuticals

    Sr. Manager Medical Affairs Project Management

    1 week ago

    Regeneron Pharmaceuticals Tarrytown, United States

    Provide project management support to the Global Medical Affairs Head and Medical Directors for our Immunology Franchise. You will support the strategic and tactical planning, budget preparation, management, forecasting, accrual management. Additiona Project Management, Operation ...

  • SGA

    Regulatory Affairs Senior Manager

    1 week ago

    SGA Hawthorne, United States

    Software Guidance & Assistance, Inc., (SGA), is searching for a Regulatory Affairs Senior Manager for a FULL TIME assignment with one of our premier Pharmaceutical Services clients in Hawthorn, NY. · Responsibilities: US Agent for all Firm's products, responsible for communi ...

  • SGA

    Regulatory Affairs Senior Manager

    4 days ago

    SGA Hawthorne, United States

    Software Guidance & Assistance, Inc., (SGA), is searching for a Regulatory Affairs Senior Manager for a FULL TIME assignment with one of our premier Pharmaceutical Services clients in Hawthorne, NY. · Responsibilities: · US Agent for all Firm's products, responsible for communic ...

  • Software Guidance and Assistance, Inc.

    Regulatory Affairs Senior Manager

    2 weeks ago

    Software Guidance and Assistance, Inc. Hawthorne, United States

    Software Guidance & Assistance, Inc., (SGA), is searching for a Regulatory Affairs Senior Manager for a FULL TIME assignment with one of our premier Pharmaceutical Services clients in Hawthorne, NY. · Responsibilities: · US Agent for all Firm's products, responsible for comm ...

  • Google

    Program Manager Iii, Government Affairs, Privacy

    2 weeks ago

    Google New York, United States

    **Minimum qualifications**: · - Bachelor's degree or equivalent practical experience. · - 5 years of experience in program or project management. Experience creating public policy · **Preferred qualifications**: · - 5 years of experience managing cross-functional or cross-team pr ...

  • NYC Health + Hospitals

    Assistant Director of Fiscal Affairs, Managed Care

    6 days ago

    NYC Health + Hospitals New York, United States

    **About NYC Health + Hospitals**: · **Empower Every New Yorker — Without Exception — to Live the Healthiest Life Possible** · NYC Health + Hospitals is the largest public health care system in the United States. We provide essential outpatient, inpatient and home-based services t ...

  • Mercy University

    Budget Analyst

    3 weeks ago

    Mercy University Tarrytown, United States

    **Job Posting Summary**: · - Budget Analyst - This position assists the Budget Director in processing and maintaining the University's annual salary and operating budgets. · - **A. Administrative/Technical/Service** · - Assist in the confidential development and reconciliation of ...

  • Hiossen

    Regulatory Affairs Manager

    4 days ago

    Hiossen Englewood Cliffs, United States

    Key Responsibilities: · Oversee the day-to-day functions of the regulatory initiatives for Hiossen Implants, Digital, and Biomaterial Solutions. · Develop regulatory strategies for new, existing, and modified medical devices and other regulated products. · Manage and submit 510( ...

  • VIVOS Professional Services, LLC

    Medical Affairs Manager

    3 weeks ago

    VIVOS Professional Services, LLC Nutley, United States

    Medical Affairs Associate Project Manager · 3 days onsite/week · This position is in a pharmaceutical company and part of the Oncology Medical Affairs Strategic Planning & Operations organization. This role would support the day-to-day operations of the US & Global Medical Affair ...

  • Glenmark Pharmaceuticals USA

    Regulatory Affairs Manager

    2 weeks ago

    Glenmark Pharmaceuticals USA Mahwah, United States

    Reporting to the Associate Director, Regulatory Affairs, this position is responsible for managing functional activities to ensure that the company s goals and objectives are met. This position also manages compliance within the department and ensure Regulatory Affairs, Manager, ...