• Regulatory Affairs Manager

    Category Regulatory Affairs
    Job Location
    Regular Full-Time
  • Overview

    MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.


    The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

    Summary of Position

    This position will be managing the regulatory aspects of one or more Company projects. This individual will work closely with senior Regulatory Affairs staff and/or cross functional team members (eg, Research, Clinical, Project Management) to develop submission timelines, outlines, and/or strategies. This position will have a variety of responsibilities to include preparation of regulatory documents, reviewing for regulatory compliance and monitoring of new guidances from various regulatory agencies.

    Responsibilities and Job Duties:

    • Managing the regulatory activities for assigned projects; therapeutic areas include oncology and autoimmune disorders
    • Working with the Director, Regulatory Affairs to design and implement global regulatory development strategies
    • Interacting with Research, Clinical, Project Management and other staff contributing to a submission regarding content and timelines; ensuring sections provided to Regulatory are consistent with internal submission format standards; reformat sections as necessary
    • Preparing and assisting in the preparation of high quality domestic and international regulatory submissions (e.g., IND (e.g., Initial IND, Briefing documents, Annual Reports and other maintenance submissions), IMPD, CTA, BLA/MAA)
    • Serving as a primary Regulatory representative on project teams by providing regulatory input and strategy
    • Interacting with FDA and other Regulatory Authorities on assigned projects as appropriate
    • Reviewing new regulatory guidances and other similar information, evaluating its potential impact on projects, and advising personnel from other departments regarding applicability and impact
    • Providing regulatory research on new products and interacting cross-functionally to develop innovative strategies on new products
    • Generating Regulatory SOPs with input from stakeholders; providing training where appropriate
    • Continuing professional development by attending regulatory-related meetings, (e.g., FDA Advisory Committee meetings, conferences, workshops)
    • Performing regulatory research tasks or scientific-based projects as requested
    • Providing support to senior Regulatory Affairs staff as requested


    Education & Experience

    • Bachelor’s degree in scientific discipline; advanced degree desirable
    • Minimum of 5 years of Regulatory Affairs experience

    Knowledge, Skills and Abilities

    • Knowledgeable regarding FDA regulations and guidances as well as international regulatory guidances and requirements (e.g., ICH)
    • Demonstrated experience resolving domestic and international regulatory issues
    • Detail-oriented with ability to work effectively both independently and on a team
    • Ability to coordinate information from various internal and external sources
    • Excellent organizational skills with the ability to multi-task on several projects
    • Excellent verbal and written communication skills including ability to discuss technical information and regulatory requirements with project teams and FDA
    • Highly flexible, adaptable and accustomed to working in a fast-paced environment

    Supervisory Responsibilities


    Preferred Skills

    • Preference for previous experience with oncology drug development
    • Expertise in MS Office; experience with Electronic Document Management Systems for preparing and finalizing regulatory submissions preferred


    MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

    Equal Opportunity Employer/Veterans/Disabled


    For more information about our commitment to equal employment opportunity, please click here.


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