Regulatory Affairs Specialist II — Submissions & Lifecycle

PROLACTA; Time; Hybrid; NOK 854,000 - 1,139,000; Full time

Benefits offered by this job

Healthcare coverage

401(k) match

Paid time off

Job summary

Prolacta Bioscience’s IT Department seeks a Regulatory Affairs Specialist II to provide regulatory execution support for assigned products, markets, and projects within defined scope. Responsibilities include submissions, registrations, renewals, lifecycle management, and health authority correspondence to ensure traceability, inspection readiness, and regulatory compliance.

The role requires a Bachelor's degree in science or related discipline with at least 3 years in Regulatory Affairs,

Qualifications

• Bachelor’s degree in science, nutrition, food science, regulatory affairs, technical, or related discipline required; advanced degree or RAC certification preferred.
• A minimum of 3 years of Regulatory Affairs or relevant regulated industry experience, preferably in biologics, biopharmaceutical, pharmaceutical, infant formula, nutrition, medical product, or similarly regulated environment, with exposure to submissions, registrations, product dossiers, renewals, notifications, health authority correspondence, lifecycle management, controlled documentation, or regulatory operations.
• Working knowledge of FDA requirements, food/infant formula and/or drug regulations, GMP principles, CMC documentation concepts, domestic and/or international regulatory frameworks, and submission, registration, lifecycle, change assessment, health authority response, and record-retention processes.
• Experience coordinating cross-functional submission or regulatory operations activities, resolving routine documentation issues, communicating status and risks, and tracking deliverables to completion.

Responsibilities

• 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 operational processes.
• Monitor applicable regulations, guidance, standards, enforcement trends, health authority expectations, agency feedback, submission outcomes, commitments, and internal learnings; analyze trends to identify potential risks, recurring issues, and improvement opportunities, and summarize findings for management review and evaluation.
• Provide practical regulatory support to peers and cross-functional stakeholders on applicable requirements, documentation standards, submission expectations, and lifecycle maintenance practices within assigned scope.
• Exercise judgment within defined policies and procedures on assigned regulatory matters; manage competing priorities, recommend practical actions, and elevate complex or high-risk issues.
• Contribute to team development by sharing knowledge, participating in process improvements, and supporting consistent application of regulatory procedures and documentation practices within assigned scope.
• Other duties as assigned.

Skills

Regulatory knowledge

Health authority liaison

Documentation tracking

Written communication

Project coordination

Microsoft Office

Education

Bachelor’s degree in science/related

RAC certification preferred

Job description

Prolacta Bioscience’s IT Department seeks a Regulatory Affairs Specialist II to provide regulatory execution support for assigned products, markets, and projects within defined scope. Responsibilities include submissions, registrations, renewals, lifecycle management, and health authority correspondence to ensure traceability, inspection readiness, and regulatory compliance.

The role requires a Bachelor's degree in science or related discipline with at least 3 years in Regulatory Affairs,