Senior Regulatory Affairs Associate

Job summary

Prepare and maintain complete, inspection-ready submissions and product dossiers for a neonatal lung surfactant, and manage health-authority questions, commitments, and meetings. Coordinate regulatory filings, change controls, stability updates, regulatory intelligence, and country filing sequences with Quality, Manufacturing, Clinical, and commercial partners.

Job details

Premature infants receive a lung surfactant only if the evidence, the manufacturing record, and the regulatory file stay aligned. This role keeps that path open: you turn clinical, quality, and CMC data into submissions regulators can trust and clinicians can use. The work protects patients and determines whether a focused neonatal program can expand without compromising integrity. Performance Objectives File complete, inspection-ready submissions and variations for a neonatal lung surfactant in priority markets, on agreed timelines and without material deficiencies. Keep the product dossier current so labeling, CMC, and clinical claims match approved evidence and current manufacturing practice. Lead health-authority interactions—questions, commitments, and meetings—so responses are sourced, accurate, and closed without avoidable delay. Run regulatory intelligence that flags changes affecting surfactant products, pediatric labeling, and pharmacovigilance before they become compliance gaps. Clear change controls, stability updates, and trial-related filings with Quality, Manufacturing, and Clinical, with rework held to exceptions. Maintain a submission tracker and archive an auditor or partner can follow from source data to approved text. Sequence country filings for distribution expansion against supply, labeling, and partner readiness. Environment & Resources You join a small, hands-on pharmaceutical team and report to the regulatory or quality lead. You work directly with CMC, clinical, and commercial colleagues, with the living dossier, the quality system, and external regulatory counsel available when a filing needs specialist review. Decisions sit close to the science; you will not wait on a large regulatory bureaucracy. Essential Qualifications Several years preparing and managing drug submissions and variations for a marketed or late-stage biologic or complex drug product. Working command of Health Canada requirements and at least one other major authority, including pediatric or neonatal considerations. Ability to read CMC and clinical data well enough to defend labeling and answer deficiency letters without rewriting the science. Proven ownership of cross-functional change control and an inspection-ready dossier. Clear writing under deadline, and comfort being the regulatory expert in a small organization. Why This Role Regulatory quality here has a direct consequence for infants in respiratory distress. Your filings move a real therapy, not a slide-deck pipeline. You help build the regulatory system of a focused manufacturer rather than maintain one already finished. Short decision lines put your judgment next to science, quality, and supply. Compensation: Salary range: $70,000- $82,000 base If you want your regulatory work to keep a critical neonatal therapy available and expanding responsibly, apply with a brief note on a filing you owned and the outcome it produced.

What you’ll do

Prepare and maintain complete, inspection-ready submissions and product dossiers for a neonatal lung surfactant, and manage health-authority questions, commitments, and meetings. Coordinate regulatory filings, change controls, stability updates, regulatory intelligence, and country filing sequences with Quality, Manufacturing, Clinical, and commercial partners.

Requirements

Several years of experience managing submissions and variations for a marketed or late-stage biologic or complex drug product, with working knowledge of Health Canada and at least one other major regulatory authority. Must be able to assess CMC and clinical data, support labeling and deficiency responses, own cross-functional change control, maintain an inspection-ready dossier, and write clearly under deadline.

Listed skills

• Cross-Functional Collaboration · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Regulatory Affairs
• Drug Submissions
• Regulatory Variations
• Health Canada Requirements
• Regulatory Intelligence
• CMC Data Review
• Clinical Data Review
• Labeling Compliance
• Health-Authority Interactions
• Deficiency Letter Responses
• Change Control
• Dossier Management
• Inspection Readiness
• Pharmacovigilance
• Cross-Functional Collaboration
• Regulatory Writing

Job areas

• Healthcare
• Legal
• Science & Research
• Manufacturing

More jobs from MaxPeople HR