£45 Per hour
Outside
Remote
Manchester
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 support and cross-functional coordination to facilitate communication among various stakeholders. The role is remote and classified as outside IR35, focusing on high-impact regulatory activities and governance.
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 clear and timely 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 regulatory affairs and project management within the pharmaceutical industry.
- Strong understanding of EU pharmaceutical standards and compliance requirements.
- Excellent communication and coordination skills.
- Ability to manage multiple priorities and identify risks proactively.
- Experience in cross-functional collaboration.
- Strong organizational skills and attention to detail.
Salary (Rate): £45 per hour
City: Manchester
Country: United Kingdom
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: Mid-Level
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.