Regulatory Affairs Specialist II

Do you want to contribute to a larger purpose to save the lives of infants in the NICU? This is Prolacta Bioscience’s mission! Take a look at this opportunity with our IT Department which is seeking a passionate individual, to fill the role of Regulatory Affairs Specialist II.

The Regulatory Affairs Specialist II provides regulatory execution support for assigned products, markets, and projects within defined scope and under appropriate management oversight. The role supports submissions, registrations, renewals, notifications, dossier maintenance, lifecycle management, regulatory operations, change assessments, and health authority correspondence by applying regulatory requirements, reviewing source documentation, coordinating cross-functional input, and preparing compliant documentation and recommendations. This position manages assigned deliverables, timelines, records, and documentation packages with focus on accuracy, completeness, traceability, and inspection readiness;

identifies routine to moderately complex risks or gaps, supports mitigation activities, participates in assigned health authority interactions, provides practical regulatory support to stakeholders, and escalates complex or high-risk issues to management.

Who Is Prolacta Bioscience?

We give babies a brighter future by unlocking the biological power of human milk. Established in 1999, Prolacta Bioscience is a privately held life sciences company that has touched the lives of more than 100,000 premature infants globally. Prolacta is the world’s leading hospital provider of 100% human milk– based nutritional products. Based in Southern California, we employ more than 300 people globally, many of whom have dedicated their lives to neonatal care.

This role will provide you with the opportunity to contribute to the growth of our organization and develop your professional skills by…

• Support assigned submissions, registrations, renewals, amendments, supplements, notifications, agency responses, and dossier maintenance activities; assess defined requirements, compile documentation, track timelines, and support deliverables through completion.
• Develop, compile, review, maintain, and provide supporting rationale for product dossiers, regulatory documentation packages, records, correspondence, approvals, licenses, registrations, certificates, commitments, decisions, and supporting evidence to support traceability, data integrity, and inspection readiness.
• Review scientific, technical, quality, manufacturing, CMC, clinical, labeling, operational, and product documents for regulatory suitability, completeness, consistency, traceability, and potential submission or market maintenance impact within assigned scope.
• Apply applicable regulations, guidance, health authority expectations, industry standards, internal procedures, and prior approvals to support submission planning, change assessments, correspondence, dossier decisions, and recommended actions.
• Coordinate assigned cross-functional regulatory activities, obtain required data, reconcile comments, address routine documentation issues, maintain trackers and timelines, communicate status and risks, and support mitigation actions.
• Support regulatory assessments of product, process, manufacturing, supplier, specification, labeling, and operational changes to determine potential submission, notification, registration, dossier update, health authority communication, or market maintenance requirements.
• Draft and revise routine health authority correspondence, meeting materials, response narratives, data summaries, justifications, deficiency responses, and supporting documentation; support assigned agency queries, clarification requests, and follow-up activities under management oversight.
• Support internal audits, external inspections, regulatory readiness activities, and periodic reviews by evaluating dossier completeness, confirming record traceability, preparing evidence packages, and responding to information requests within assigned scope.
• Support development and improvement of regulatory templates, submission checklists, dossier tools, controlled documents, work instructions, trackers, and…