More jobs:
Professional Regulatory Affairs - Lifecycle Management - Non-Medicines
Job in
Morristown, Morris County, New Jersey, 07960, 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
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.
- 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.
- 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.
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×