Jobs
>
Deerfield Beach

    Manager Regulatory Affairs - Deerfield, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences Deerfield, United States

    3 weeks ago

    Default job background
    Description
    Responsibilities:
    • The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes.
    • This person is instrumental in the design, development, and maintenance of global regulatory processes and business solutions.
    • This is a meaningful individual contributor who will partner with key business, functional and business partners to ensure commercial objectives are achieved.
    • Accountable for all operational aspects including owning, creating and/or maintaining CCDS/CCSI/RSI documentation, delivering, maintaining, and driving regulatory systems, databases, and labeling processes that support therapeutic and combination products.
    • Lead the initial development, approval, and ongoing compliance of product labeling content throughout the product life cycle; track status and maintain documents in controlled process and systems workflows; lead reviews and manage the documents through approvals and governance by cross-functional executive and subject matter authority leadership.
    • Make decisions regarding patient safety signals, indications, risk and other sophisticated change or regulated content creation/modification triggers.
    • Support global implementation of CCDS/CCSI/RSI into country-specific labeling by developing and approving implementation of complex global and local labeling and other regulated solutions in accordance with the end-to-end regulated content, labeling processes, and commercial objectives, including reviewing deviations, exemptions, and deferrals.
    • Participate in the execution of regulatory labeling and content strategies for new products and ongoing compliance for products already on the market, including monitoring, evaluating, and internally communicating new and existing applicable regulatory requirements.
    • Lead or support global technology, process, and solution initiatives to standardize, and enable standard process in labeling and content management, including requirements, use cases and translations.
    • Deliver responses, solutions, and find opportunities to improve based upon quality initiatives, including audits and risk mitigation.
    • Perform gap analysis on regulated content management processes; design, develop, assess, improve, implement, and maintain associated complex and simple Global Regulatory Affairs and Quality processes and business solutions.
    Requirements:
    • Bachelor's degree in pharmacy, biochemistry or similar science related field preferred.
    • Minimum 5 years of pharmaceutical regulatory or regulated content management (e.g., labeling, or Company Core Data Sheets) experience.
    • Ability to run sophisticated projects and timelines in a matrix team environment.
    • Strong project management and organizational skills.
    • Ability to independently identify compliance risks and raise when necessary.
  • ADMA BIOMANUFACTURING LLC

    Associate Director, Regulatory Affairs

    1 week ago

    ADMA BIOMANUFACTURING LLC Boca Raton, United States

    Job Details · Job Location · ADMA Biologics - Boca Raton, FL · Travel Percentage · Up to 50% · Job Shift · Day · Description · ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infecti ...

  • Discover

    Senior Regulatory Affairs Process Specialist

    1 week ago

    Discover Deerfield, United States

    Discover. A brighter future. · With us, youll do meaningful work from Day 1. Our collaborative culture is built on three core behaviors: We Play to Win, We Get Better Every Day & We Succeed Together. And we mean it we want you to grow and make a difference at one of the world's ...

  • iRhythm Technologies

    Staff Regulatory Affairs Specialist

    3 days ago

    iRhythm Technologies Deerfield, United States

    **Boldly innovating to create trusted solutions that detect, predict, and prevent disease.** · - Discover your power to innovate while making a difference in patients' lives. _iRhythm is advancing cardiac care Join Us Now_ · At iRhythm, we are dedicated, self-motivated, and drive ...

  • Baxter Healthcare Corporation

    Specialist, Global Regulatory Affairs

    3 weeks ago

    Baxter Healthcare Corporation Deerfield, United States

    This is where you save and sustain lives · At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outc ...

  • ADMA Biologics Inc

    Associate Director, Regulatory Affairs

    3 weeks ago

    ADMA Biologics Inc Boca Raton, United States

    Job Details · Job Location: ADMA Biologics - Boca Raton, FL · Salary Range: Undisclosed · Travel Percentage: Up to 50% · Job Shift: Day · Description · ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients ...

  • Discover

    Senior Regulatory Affairs Process Specialist

    2 weeks ago

    Discover Deerfield, United States

    Central point of contact for management of the supervisory findings process, tracking and reporting supervisory finding from issuance through validation and regulator notification. Manage Board, Committee and Management reporting process. Maintain KR Regulatory Affairs, Specialis ...

  • Discover

    Senior Regulatory Affairs Process Specialist

    1 week ago

    Discover Deerfield, United States

    Discover. A brighter future. · With us, you'll do meaningful work from Day 1. Our collaborative culture is built on three core behaviors: We Play to Win, We Get Better Every Day & We Succeed Together. And we mean it - we want you to grow and make a difference at one of the world ...

  • Teva Pharmaceuticals

    Regulatory Affairs Associate III

    6 days ago

    Teva Pharmaceuticals Fort Lauderdale, United States

    Regulatory Affairs Associate III · Date: May 21, 2024 · Location: · Weston, United States, Florida, 33331 · Company: Teva Pharmaceuticals · Job Id: 55591 · **Who we are** · Together, we're on a mission to make good health more affordable and accessible, to help millions around th ...

  • Aequor Technologies

    Regulatory Affairs Associate I

    1 week ago

    Aequor Technologies Hollywood, United States

    : · Shift/days/ some weekends Mon-Fri · Length of the assignment 6 months with possible extension · Required: · *****bilingual read/write in Spanish/English.***** · Attach a test showing basic understanding of Excel, Word, Outlook · Required Screens: · 10 panel drug · Bac ...

  • CHS Recruiting

    Vice President of Regulatory Affairs

    1 week ago

    CHS Recruiting Palm Beach, United States

    Job Description · Job DescriptionOPEN POSITION: · Vice President of Regulatory Affairs - Medicare Advantage Health Plan · COMPENSATION: · - $150,000 to $175,000 Base Salary, negotiable based on experience · - Annual Bonus · - Health / Dental / Vision / Life Insurance · - LTD / ...

  • Teva Pharmaceutical Industries

    Regulatory Affairs Associate III

    2 weeks ago

    Teva Pharmaceutical Industries Fort Lauderdale, United States

    Who we are · Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Wor ...

  • Tevapharm

    Regulatory Affairs Associate III

    3 weeks ago

    Tevapharm Fort Lauderdale, United States

    Press Tab to Move to Skip to Content Link · Select how often (in days) to receive an alert: · Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across near ...

  • Lundbeck

    Director Medical Affairs Psychiatry

    2 weeks ago

    Lundbeck Deerfield, United States

    Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpos ...

  • Lundbeck

    Director Medical Affairs Psychiatry

    3 weeks ago

    Lundbeck Deerfield, United States

    Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpos ...

  • Lundbeck

    Associate Director VYEPTI Consumer Marketing

    2 weeks ago

    Lundbeck Deerfield, United States Full time

    Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpos ...

  • Lundbeck

    Associate Director VYEPTI Consumer Marketing

    3 weeks ago

    Lundbeck Deerfield, United States

    Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpos ...

  • Lundbeck

    Associate Director VYEPTI Consumer Marketing

    3 weeks ago

    Lundbeck Deerfield, United States

    Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpos ...

  • Lundbeck

    Associate Director of Neurology HCP Marketing

    3 weeks ago

    Lundbeck Deerfield, United States

    Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpos ...

  • Lundbeck

    Associate Director Consumer Marketing Psychiatry

    3 weeks ago

    Lundbeck Deerfield, United States

    Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpos ...

  • Lundbeck

    Associate Director Consumer Marketing Psychiatry

    3 weeks ago

    Lundbeck Deerfield, United States

    Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpos ...