£45 Per hour
Outside
Remote
England, United Kingdom
Summary: The role of Part-Time Pharmaceutical/Regulatory Affairs Project Manager involves overseeing regulatory submissions and operational activities to ensure compliance with EU pharmaceutical standards. The position requires strategic prioritization and cross-functional coordination, acting as a liaison among various departments and stakeholders. The manager will also participate in governance meetings to track progress and resolve challenges. This is a remote contract position classified as outside IR35.
Key Responsibilities:
- Monitor and manage the progress of regulatory submissions, compliance tasks, and operational deliverables.
- Track key milestones across product lifecycle activities and proactively identify risks.
- Partner with EU Regulatory Affairs Leads and the RA Director to define and adjust priorities.
- Act as the central liaison for all deliverables-related queries across various functions.
- Facilitate communication between internal and external stakeholders.
- Provide structured updates to senior leadership on regulatory progress and key deliverables.
- Participate in monthly operational and regulatory governance meetings.
- Document and track key decisions, action items, and follow-ups.
Key Skills:
- Experience in pharmaceutical regulatory affairs and project management.
- Strong understanding of EU pharmaceutical standards and compliance.
- Excellent communication and coordination skills.
- Ability to prioritize and manage multiple tasks effectively.
- Experience in cross-functional collaboration.
- Proficiency in tracking and reporting on project milestones.
Salary (Rate): £45.00/hr
City: undetermined
Country: United Kingdom
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: Other
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.