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 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 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
Internal Number: 2018-1243
About MacroGenics, Inc.
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.