Project Manager – DDIT Development Regulatory Affairs (RA)

As the Project Manager – DDIT Dev. RA, you may lead strategic IT and virtual initiatives focused on regulatory affairs inside the drug development lifecycle. You will collaborate with cross-functional groups which includes IT, facts technological know-how, regulatory specialists, and external vendors to make certain project success from initiation to transport.

This is a assignment-important role in accelerating Novartis’ digital transformation journey in regulatory operations, ensuring compliance, efficiency, and innovation.

🛠️ Key Responsibilities

• Lead and control cease-to-stop IT/virtual tasks inside Regulatory Affairs, ensuring alignment with business goals
• Define challenge scope, goals, timelines, and useful resource wishes in collaboration with stakeholders
• Apply venture control methodologies (Agile/Waterfall) to deliver solutions on time and inside finances
• Collaborate intently with regulatory, improvement, and technical teams to align IT solutions with compliance requirements
• Ensure right documentation, danger management, and nice warranty practices all through the assignment lifecycle
• Manage external providers, specialists, and software carriers as required
• Report frequently on mission development, KPIs, and risks to senior control
• Drive non-stop improvement in undertaking shipping and assist virtual method execution

✅ Required Qualifications

🎓 Education:

• Bachelor’s or Master’s diploma in Computer Science, Engineering, Life Sciences, or a related subject
• Project Management certification (e.G., PMP, PRINCE2, Agile/Scrum Master) desired

💼 Experience:

• Minimum 5–eight years of venture management experience inside the existence sciences or pharmaceutical region
• Proven tune report of main IT or virtual initiatives in Regulatory Affairs or Drug Development
• Strong understanding of regulatory compliance requirements (e.G., GxP, FDA, EMA policies)
• Familiarity with Veeva Vault, Regulatory Information Management Systems (RIMS), or similar systems is a sturdy benefit

🧠 Skills:

• Excellent organizational, leadership, and conversation abilties
• Ability to control a couple of complicated initiatives concurrently
• Strong stakeholder management and move-useful collaboration capabilities
• Proficiency in challenge control equipment (e.G., JIRA, MS Project, Smartsheet, Trello)

🌟 Preferred Qualifications

• Background in structures implementation or virtual innovation in a regulated surroundings
• Knowledge of data governance, metadata, and virtual tools utilized in Regulatory Affairs
• Experience operating in international teams and multi-cultural environments
• Understanding of cloud technology, AI/ML in regulatory submissions or automation is a plus

🌐 Why Join Novartis?

Working at Novartis means being a part of a international assignment to transform medicinal drug and improve get admission to to healthcare. In this role, you’ll be contributing to strategic regulatory projects and modernizing the equipment and structures that underpin worldwide drug development.

Benefits Include:

• Competitive profits and overall performance-based totally incentives
• Flexible operating preparations (faraway/hybrid)
• Health and wellness packages
• Career improvement and training possibilities
• Inclusive paintings culture centered on innovation and collaboration
• Global mobility alternatives for excessive performers