Pharmaceutical Project Manager P/T outside IR35

Pharmaceutical Project Manager P/T outside IR35

Posted 1 day ago by 1757649106

£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

Detailed Description From Employer:

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.