MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next-generation antibody-based technologies. Our team of 400+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer. Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology 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 with 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 including preparation of regulatory documents, reviewing for regulatory compliance, and monitoring of new guidance 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)
Interacting with FDA and other Regulatory Authorities on assigned projects as appropriate
Reviewing new regulatory guidance 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
Sr. Regulatory Affairs Manager
Bachelor’s degree in a scientific discipline; advanced degree desirable
Minimum of 7 years of Regulatory Affairs experience
Regulatory Affairs Manager
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 guidance as well as international regulatory guidance and requirements (e.g., ICH)
Demonstrated experience resolving domestic and international regulatory issues
Detail-oriented with the 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 the ability to discuss technical information and regulatory requirements with project teams and FDA
Highly flexible, adaptable, and experienced in a fast-paced environment
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 firstname.lastname@example.org or call (301) 354-3566 and/or 711 for TTD/TTY service.
Equal Opportunity Employer/Veterans/Disabled
We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.
To promote the health and well-being of our employees and ensure business continuity, MacroGenics requires all new hires to be fully vaccinated for COVID-19 by his/her start date. A new hire will need to either (a) establish that they have been fully vaccinated or (b) obtain an approved exemption as an accommodation.
MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies.