Regulatory Affairs Fellow STE

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope :

The post-doctoral Regulatory Affairs Fellow will be assigned to work with a more senior regulatory affairs member on project / or product teams / task forces and will assist in document preparation and on project-related issues. Responsible for oversight of submission projects and interactions outside the Regulatory Affairs Pharmacovigilance (RAPV) Department on routine issues and questions. Uses technical expertise gained from regulatory affairs and other pharmaceutical industry training / experience to meet objectives.

Responsibilities and Accountabilities :

• Coordinates, compiles and facilitates submission of regulatory documents within existing regulatory framework (e.g., INDs, NDAs, sNDAs, briefing documents)
• Participates in the preparation of responses to health authorities communications and maintains filings and approvals in accordance with applicable regulations / and or legislation
• Provides project support for more senior regulatory affairs member to assist in project completion while learning new regulatory skills
• Works on day-to-day interactions with the project team and knows when to rely upon appropriate supervision for more complex issues and questions
• Interacts with project teams, multiple departments and position levels including but not limited to global staff in RAPV, Medical and Development functions, and Commercial on a regular basis, as well as with administrative staff at regulatory agencies on a project basis for specific submissions and administrative matters.
• Accesses, understands and applies regulatory guidance and / or regulations to ensure compliance with routine regulatory submissions
• Apply scientific knowledge to assigned projects, and use working knowledge of relevant regulations and guidelines to assist in the success of projects and programs
• Participate in health authority meetings, with senior regulatory supervision, as appropriate
• Collaborate with senior regulatory staff on the development of regulatory strategies and drug development pathways
• Position has direct impact on the company’s ability to meet goals and timelines related to regulatory submissions and business plans.
• Position challenges incumbent to manage multiple project goals and timelines.
• Work with / oversee pharmacy students