Sr. Regulatory Affairs Specialist

Bachelor’s degree in Life Sciences, Engineering or English preferred, or in a related field commensurate with experience
3+ years of experience authoring and working with Biologics, Pharmaceutical, Device or Tissue regulatory submissions
Knowledge of Biologics, Pharmaceutical and Device or Tissue regulations and Quality System regulation requirements (e.g., 21 CFR Part 820, 21 CFR Part 1271, 21 CFR Part 210/211, 21 CFR Part 600, ISO 13485, ISO 9001, ISO 14971, AATB accreditation guidelines)
Knowledge of ICH’s eCTD/eCTD EU specifications
Demonstrated ability to effectively communicate both verbally and in writing
Successful history of handling multiple tasks, prioritizing activities, and scheduling work to meet business needs
Ability to be flexible with changing priorities
Experience with application of risk management processes
Ability to travel approximately 20%

Prepare, author, edit, compile, and review high-quality, clearly messaged documents in compliance with regulatory standards for submission to regulatory agencies and health authorities.
Lead document comment resolution for content issues and questions arising during the authoring process. Assist with the coordination of the review, approval, QC, and other activities involved in the production of regulatory documents.
Perform data analysis and comprehensive literature reviews to support the US or International regulatory submissions including regulatory pathway justifications, expanded indications, etc.
Collaborate with the preparation of International regulatory dossiers and submissions.
Maintain knowledge of biologics, pharmaceutical, device, and tissue regulations, guidance, and standards.
Participate in cross-functional projects including new product development, marketing, and design review activities.
Supports regulatory review of labels, labeling, and promotional materials.
Collaborates with the development of regulatory training programs and procedures.
Assist in complaint handling and analysis.
Maintain corporate regulatory files.
Comply with all company policies, procedures, and SOPs.