Sr. Regulatory Affairs Specialist

Cerus

About The Position

Cerus aims to be the global leader and trusted partner of blood centers and hospitals whose technology, services, and commitment are the lifeblood of safe and accessible blood for patients around the world. Summary & Scope of Position: Coordinate and prepare documents for submissions to regulatory agencies worldwide, as appropriate by project.

Requirements

Bachelor’s degree in a related scientific discipline with a minimum of 5 years regulatory experience in a biotechnology, pharmaceutical, or medical device company.
Proven ability to work effectively in a fast-paced environment, managing multiple competing priorities and deadlines.
Demonstrated ability to work independently, take initiative, and drive tasks to completion within established timelines.
Strong communication skills, including interpersonal, written, verbal, and active listening abilities.
Effective time management skills, with the ability to plan, prioritize, and manage multiple tasks and schedules.
Highly detail-oriented with a strong focus on accuracy and quality.

Responsibilities

Coordinate and prepare regulatory submissions for EMEA, LATAM, and APAC regions, including planning, authoring, and reviewing submission documents. Interface cross-functionally to obtain required components and ensure submissions meet applicable regulatory requirements and timelines.
Review submission-related documentation from clinical, pre-clinical, research, development, and manufacturing functions to ensure consistency with regulatory filings and compliance with applicable regulations.
Maintain current knowledge of EU and international regulatory requirements, guidelines, and trends. Assess the impact of regulatory changes on assigned projects and provide recommendations to regulatory and cross-functional teams.
Support and contribute to the development and execution of regulatory strategies in collaboration with senior Regulatory Affairs personnel.
Participate in and/or represent Regulatory Affairs on cross-functional project teams, ensuring regulatory considerations are appropriately integrated into project plans.
Maintain accurate and up-to-date regulatory records and documentation, including submission archives and agency correspondence.
Work independently on routine assignments, with general guidance provided for new or complex tasks.
Perform other related duties as assigned.