Part-Time Pharmaceutical / Regulatory Affairs Project Manager, remote working, outside IR35, contract job
Oversight of Regulatory and Operational Activities
* Monitor and manage the progress of regulatory submissions, compliance tasks, and operational deliverables to ensure alignment with EU pharmaceutical standards and timelines.
* Track key milestones across product lifecycle activities (e.g., MAA, variations, renewals) and proactively identify risks that may impact regulatory or commercial delivery.
Strategic Prioritisation Support
* Partner with EU Regulatory Affairs Leads and the RA Director to define and adjust priorities based on evolving regulatory requirements, product strategy, and market needs.
* Ensure focus remains on high-impact regulatory and operational activities, supporting teams in navigating urgent health authority requests or critical compliance issues.
Cross-Functional Coordination and Communication
* Act as the central liaison for all deliverables-related queries across Regulatory Affairs, Pharmacovigilance, Medical Affairs, and Commercial functions.
* Facilitate clear and timely communication between internal and external stakeholders (e.g., health authorities, affiliates) to maintain alignment with project goals.
* Provide structured updates to senior leadership and stakeholders on regulatory progress, submission status, and key deliverables.
Governance and Meeting Engagement
* Participate in monthly operational and regulatory governance meetings to review progress, resolve challenges, and align on strategic objectives.
* Document and track key decisions, action items, and follow-ups to ensure accountability and continuous progress.