What are the responsibilities and job description for the Regulatory Affairs Specialist position at Mariana Oncology?
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
