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Professional Regulatory Affairs - Lifecycle Management - Non-Medicines

Job in Morristown, Morris County, New Jersey, 07960, USA
Listing for: Scorpion Therapeutics
Full Time position
Listed on 2026-08-30
Job specializations:
  • Business
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 110000 - 160000 USD Yearly USD 110000.00 160000.00 YEAR
Job Description & How to Apply Below

Description Overview

You will support Perrigo’s non-medicinal portfolio (cosmetics, VMS, general products, and other non-medicinal classifications such as medical devices) across the product lifecycle, developing and executing regulatory strategies to deliver compliant regulatory outcomes.

Responsibilities
  • Manage lifecycle management activities: prepare, maintain, and deliver regulatory documentation, product/technical files, notifications, registrations, and supporting records in line with global requirements and business priorities.
  • Identify regulatory risks and support mitigation; ensure timely, compliant filings and documentation updates to maintain supply continuity, consumer safety, and market access.
  • Independently manage complex post-market lifecycle changes end-to-end; seek alignment for high-risk decisions and provide risk-based recommendations within delegated authority.
  • Lead work streams/workstream delivery across multiple products or markets.
  • Assess and manage complex post-market lifecycle changes; work with cross-functional teams/authorities to identify data requirements and update regulatory documentation/product files.
  • Determine regulatory pathway/classification for complex changes; provide rationale and risk-based recommendations.
  • Establish/maintain/review/approve/update product information files, technical files, regulatory records, and supporting documentation.
  • Manage central notifications, registration filings/renewals, documentation updates; prepare files, answer RFIs, and manage timelines.
  • Develop/approve updated master labels; support implementation readiness and approval traceability.
  • Support audits and CAPA reporting/follow-up; mitigate risks to avoid supply disruption.
  • Represent Regulatory in project teams; communicate requirements, risks, and proposals.
  • Support RA authority communications; respond to lifecycle queries.
  • Suggest and execute process improvements to improve quality/predictability of lifecycle delivery.
  • Ensure robust handover/transition of product information files, technical documentation, regulatory decisions, and implementation requirements.
Experience Required / Qualifications
  • Typically 3–5 years in Regulatory Affairs; relevant scientific/technical degree preferred.
  • Experience across lifecycle submissions, dossier maintenance, and cross-functional issue resolution.
  • Ability to represent Regulatory, lead work streams with increasing independence, and manage complex regulatory matters.
Benefits
  • Competitive compensation; benefits to support you and your family; career development opportunities.
  • Hybrid working flexibility: ability to work two days a week from home in many roles.
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