Regulatory Affairs Director jobs in the United States

Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Senior Regulatory Affairs Director, Global Regulatory Strategy
  • 10001056 - Director Regulatory
  • Boston, MA FULL_TIME
  • Do you have expertise in, and passion for, Regulatory AffairsWould you like to apply your expertise and channel the scientific capabilities in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

    At AstraZeneca, we are using cell therapy to revolutionize the treatment of life-threatening immune-mediated diseases. We put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

    AstraZeneca’s pipeline of innovative medicines is growing within  Immunology Cell Therapy , one of our major therapy areas. To meet the increasing demand of regulatory expertise, we continue to expand our regulatory functions through the recruitment of Regulatory Affairs Strategists(at Director and Senior Director level).  You will work across disciplines in an atmosphere of collaboration and inclusion where Regulatory Affairs is a respected voice and considered an equal partner in the business.

    The Senior Regulatory Affairs Director (SRAD), Global Regulatory Strategy will be responsible for overseeing the development and implementation of global regulatory strategies for assigned products in the Cell Therapy Immunology area, with the intention of achieving successful registration and lifecycle management to serve patient needs. 

    This individual will, with a high sense of urgency, lead cross-Regulatory teams and be accountable to provide key regulatory input to Global Project and Franchise Teams (GPTs/GFTs) deliverables. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.

    You will be responsible for:

    • Providing regulatory strategic oversight for products and/or projects in the relevant therapeutic areas/portfolio, as assigned, aligned to overall Enterprise objectives through initial registration and subsequent lifecycle management.
    • Lead and support staff in preparation for regulatory authority meetings and provide input to submission strategy and other critical regulatory documents. May represent Astra Zeneca as point contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders.
    • Provide input to internal Governance and advisory bodies from which GRA staff can seek insight on strategic and procedural/operational issues as they arise.
    • Actively collaborate with Senior Management and Enterprise functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide portfolio or therapeutic level regulatory insight and broader drug development expertise.
    • Actively be up to date on latest regulatory requirements and trends.
    • Can provide support as needed to Business Development activities of the Enterprise, notably supporting Regulatory due diligence, gap assessment and resource needs.
    • Ensure exemplary behavior, leadership, ethics and transparency within the Enterprise, with Health Authorities and other external stakeholders.

    Essential for the Role:

    • Bachelor’s Degree in a scientific or pharmaceutical discipline
    • 10 years of Regulatory experience in the pharmaceutical industry, with significant track record on Global Strategies.
    • Strong knowledge of drug development and regulatory policy in immune-mediated diseases or other complex therapy areas, coupled by excellent scientific and business judgment.
    • Experience providing strategic regulatory advice for the global development of products in several major jurisdictions such as EU, US, China, Japan through all stages of development including pre-approval and marketed assets.
    • Successful track record in registering and overseeing regulatory strategies for assets.
    • Ability to manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion.
    • Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization, especially Senior Management.
    • Strong interpersonal, and written/verbal communication skills.
    • Proven track record practicing sound judgment as it relates to risk assessment
    • Highly conversant and knowledgeable of new and emerging regulations and guidances. Understanding of GxPs at relevant areas and solid understanding of where to seek and how to interpret regulatory information.
    • Experience in cell therapy development is a plus

    Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.

    Why AstraZeneca?

    At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

    So, what’s next!

    Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

    Where can I find out more?

    AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

  • 11 Days Ago

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Global Oncology Pediatric Regulatory Strategist (Senior Regulatory Affairs Director)
  • 10001056 - Director Regulatory
  • Gaithersburg, MD FULL_TIME
  • The Senior Regulatory Affairs Director (SRAD) responsible for oncology paediatric regulatory strategy (OPRS) serves as the regulatory representative on the AZ Paediatric Oncology Development Team (POD...
  • 2 Days Ago

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pharmaceutical plant director
  • Regulatory Affairs Associates
  • Southfield, MI FULL_TIME
  • Overview We are seeking a highly experienced Pharmaceutical Manufacturing Director to lead our production and supply chain operations. The ideal candidate will have a deep understanding of lean manufa...
  • 1 Month Ago

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Regulatory Affairs Specialist
  • Regulatory Affairs Professionals Society
  • Rockville, MD FULL_TIME
  • This job offer is not available in your country. Details Posted : 30-Sep-24 Location : Rockville, Maryland Type : Full Time Salary : $90k-$110k / annually Categories : European Union Regulatory Affair...
  • 28 Days Ago

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Director of Translational Regulatory Science
  • 10001224 - Assoc Director Regulatory
  • Gaithersburg, MD FULL_TIME
  • Are you a strategically focused Regulatory professional who would like to play an integral part in bringing life changing Oncology medicines to patients? If so, please join us! At AstraZeneca, we work...
  • 1 Month Ago

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Global Regulatory Affairs Strategy Director - Oncology
  • 10001196 - Assoc Director Reg Drug Proj Del
  • Gaithersburg, MD FULL_TIME
  • Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on!About AstraZeneca A...
  • 24 Days Ago

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Director, High Throughput Process Automation
  • Sarepta Therapeutics, Inc.
  • Columbus, OH
  • Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership p...
  • 10/31/2024 12:00:00 AM

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Director, Lead 340B Consultant
  • Cardinal Health
  • Columbus, OH
  • Cardinal Health's Innovative Delivery Solutions (IDS) business helps providers transform hospital pharmacies into a stra...
  • 10/30/2024 12:00:00 AM

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Continuous Improvement Manager
  • LSI ADL TECHNOLOGY LLC
  • Columbus, OH
  • Build your Career with an Industry Leader Headquartered in Cincinnati, LSI Industries (NASDAQ: LYTS) specializes in the ...
  • 10/30/2024 12:00:00 AM

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Tax Advisory Manager
  • Amentum
  • Columbus, OH
  • The **Tax Advisory Manager** will report to the Tax Advisory Senior Director and will be responsible for assisting with ...
  • 10/29/2024 12:00:00 AM

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Senior Funding and Award Management Specialist Job Details | Black & Veatch Family of Companies
  • Black & Veatch
  • Columbus, OH
  • **Senior Funding and Award Management Specialist** Date: Oct 29, 2024 Location: US Company: Black & Veatch Family of Com...
  • 10/29/2024 12:00:00 AM

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Global Benefits Director Job Details | Black & Veatch Family of Companies
  • Black & Veatch
  • Columbus, OH
  • **Global Benefits Director** Date: Oct 22, 2024 Location: Overland Park, KS, US US Company: Black & Veatch Family of Com...
  • 10/29/2024 12:00:00 AM

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Emergency Manager
  • UC Davis Health
  • #CA-SS Primarily responsible for the development of processes and monitoring of regulatory compliance to develop and mai...
  • 10/27/2024 12:00:00 AM

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Director Total Rewards - Remote East or Central US
  • Confidential
  • Columbus, OH
  • The Total Rewards Director key responsibility is for shaping the total rewards agenda across the Americas region, provid...
  • 10/27/2024 12:00:00 AM

Income Estimation for Regulatory Affairs Director jobs
$174,990 to $244,631