Senior Project Manager – Pharma (Approval & Delivery)

This is a remote position.

Job Description: Senior Project Manager – Pharma (Approval & Delivery)

Location: Remote / Offshore

Employment Type: Full-time

Domain: Pharmaceutical & Life Sciences

Position Overview

We are seeking an experienced Senior Project Manager (Pharma) to join our team in an offshore capacity. In this role, you will be responsible for leading pharmaceutical projects from initial stage-gate governance and regulatory approval through to final execution and global delivery.

The ideal candidate will possess deep pharmaceutical industry expertise, strong cross-functional stakeholder management skills, and a proven track record of managing complex pharma projects within strict compliance and regulatory standards.

Key Responsibilities

1. Governance & Project Approval

• Lead projects through internal stage-gate governance processes, securing executive and steering committee approvals.
  
• Collaborate with Regulatory Affairs, Quality Assurance (QA), R&D, and Quality Control (QC) to ensure all compliance documentation (e.g., FDA, EMA, cGMP) is aligned prior to launch.
  
• Develop comprehensive business cases, project charters, resource plans, and risk management strategies to justify project scope and budget.
  

2. End-to-End Delivery Management

• Drive execution of cross-functional pharmaceutical projects across clinical, technical, manufacturing, or commercial domain streams.
  
• Monitor project milestones, critical path activities, budgets, and KPIs, ensuring deliverables meet strict timeline and quality targets.
  
• Manage vendor, CMO (Contract Manufacturing Organization), and external partner relationships to ensure seamless operational integration.
  

3. Stakeholder & Risk Management

• Serve as the central point of contact between offshore delivery teams and onshore business partners/executives.
  
• Identify, mitigate, and escalate project risks, regulatory roadblocks, and scope creep proactively.
  
• Provide clear, concise status reporting to senior leadership and global project steering committees.
  

Requirements

Qualifications & Requirements

• Education: Bachelor’s or Master’s degree in Pharmacy, Chemistry, Life Sciences, Bio-Engineering, or a related field. PMP, PRINCE2, or Agile certification is highly preferred.
  
• Experience: 6–10+ years of direct project management experience within the Pharmaceutical / Life Sciences sector.
  
• Regulatory Knowledge: Deep understanding of pharma development life cycles, cGMP standards, regulatory approval frameworks (FDA/EMA), and Quality Management Systems (QMS).
  
• Delivery Track Record: Demonstrated experience taking pharmaceutical projects from initiation and approval through implementation and closeout.
  
• Offshore Collaboration: Proven capability to operate effectively in remote/offshore delivery setups, working across time zones with strong self-governance.
  
• Language & Communication: Exceptional written and verbal English communication skills, with confidence leading discussions with onshore UK leadership.
  

Key Competencies

• Strategic Thinking & Analytical Skills
  
• High Rigor in Risk & Compliance Management
  
• Excellent Stakeholder Negotiation & Influence
  
• Adaptability in Fast-Paced Regulatory Environments