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Professional Regulatory Affairs - Lifecycle Management - Non-Medicines
Job in
Westland, Wayne County, Michigan, 48186, USA
Listed on 2026-08-30
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-08-30
Job specializations:
-
Business
Regulatory Compliance Specialist
Job Description & How to Apply Below
Description Overview
Regulatory Affairs Professional within Non‑Medicinal Lifecycle Management—support non‑medicinal portfolio (cosmetics, VMS, general products, and other non‑ medicinal classifications such as medical devices) across the product lifecycle. Contribute to regulatory strategy and execution to deliver compliant, high-quality regulatory outcomes.
Responsibilities- Manage lifecycle management activities: prepare/maintain/deliver regulatory documentation, product/technical files, notifications, registrations, and supporting records per global requirements.
- Identify regulatory risks, support mitigation, and ensure timely, compliant regulatory filings and documentation updates to maintain supply continuity, consumer safety, and market access.
- Independently manage complex post‑market lifecycle changes and related filings/updates across products and markets; lead work streams within LCM remit.
- Assess and manage complex post‑market lifecycle changes with cross‑functional teams/authorities; identify data requirements and update regulatory documentation/product files.
- Determine regulatory pathway/classification for complex changes with clear rationale and risk‑based recommendations; maintain regulatory intelligence.
- Establish/maintain/update product information files, technical files, regulatory records and supporting documentation in compliance with applicable legislation.
- Manage central notifications, registration filings, renewals, documentation updates; prepare files, answer RFIs, manage timelines; develop/update master labels.
- Support audits / CAPA follow‑up and mitigate risks to avoid supply disruption.
- Represent Regulatory in project teams; communicate requirements, risks, and proposals; support improvements to lifecycle processes.
- Ensure robust handover/transition of regulatory documentation and implementation requirements at launch and post‑market.
- Typically 3–5 years in Regulatory Affairs; relevant scientific/technical degree preferred.
- Experience with lifecycle submissions, dossier maintenance, and cross‑functional issue resolution.
- Competitive compensation; benefits for you and your family; career development opportunities.
- Hybrid work: ability to work two days/week from home in many roles.
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