Regulatory Affairs Specialist

Reporting:

Director, Global Regulatory Affairs

Description:

We are seeking an experienced Regulatory Affairs Specialist to join Mariana's Regulatory Affairs organization, advancing personalized medicine and radiopharmaceuticals. This team member will work cross-functionally to provide critical regulatory guidance throughout the product development lifecycle, manage execution of regulatory plans, submission preparation, and the overall program life cycle management.

Illustrative Breadth of Responsibilities:

• Coordinate, track and compile document packages for regulatory submissions
• Create and maintain detailed records of all regulatory projects, providing a clear audit trail and facilitate ongoing compliance
• Maintains regulatory files and data systems
• Maintains positive and cooperative communications and collaboration with all levels of employees; contractors, and vendors
• Interact with internal regulatory staff and external vendors to facilitate on-time publishing and submission of regulatory documents
• Assist in the development, implementation, and maintenance of document standards, templates, and procedures related to the formatting and publishing of electronic submissions and best practices in the eDMS
• Manage multiple requests, meeting all timelines, and ensuring all updates are captured
• Participate on project teams as Regulatory Operations representative
• Write and update SOP, WI, and conducts internal training, as needed
• Provides regulatory support for implementation of new systems and processes
• Monitor and analyze regulatory information systems data; and coordinates actions to address issues
• Coordinate execution and archive, information requests from regulatory agencies
• Maintain regulatory files and associated spreadsheets, reports, documents, including periodic reviews

Requirements/Skills:

• Pharmacist degree or bachelor's degree in Regulatory Affairs or science with at least three years of experience working in a Regulatory Affairs environment in the pharmaceutical or biotechnology industry
• Experience working with radiopharmaceuticals will be considered as a plus
• Understand fundamental global regulatory and quality system requirements
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Multitasks, prioritizes and meets deadlines in a timely manner
• Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements
• Good understanding of the Regulations for US, EU, Canada, and other geographies is preferred
• Strong organizational and follow-up skills, as well as attention to detail

• Ability to work within a team and as an individual contributor in a fast-paced, changing environment

Mariana Oncology's Principles

• Building a Legacy
• Execution Excellence
• Courage of our Convictions