Project Manager, Regulatory Compliance Specialist

About Site

The newly launched manufacturing facility on Adair Blvd marks a pivotal expansion of Catalent’s Zydis® technology, a globally renowned, fast-dissolve oral dosage form that has transformed the lives of millions of patients worldwide. This is your opportunity to join a dedicated team at the forefront of pharmaceutical manufacturing. At Adair, you’ll play a vital role in the startup of a site built for innovation and excellence, from installation and qualification to regulatory approval and commercial manufacturing.

We have an opportunity for a Project Manager to join our team and lead a portfolio of complex, cross-functional business projects within Catalent Adair - Zydis®. You will ensure successful delivery of projects such as infrastructure upgrades, equipment acquisitions, technical transfer, process development, validation, and scale-up. This role involves managing timelines, resources, budgets, and stakeholder expectations while meeting quality, regulatory, and EH&S standards.

You will play a key role in ensuring compliance with Catalent policies and driving project success in a cGMP-regulated CDMO environment.

Shift: Typical Working Hours will be Monday-Friday 8 AM - 4:30 PM

Location:

Adair, ON

100% Onsite

• Lead end-to-end project planning, execution, and governance for multiple concurrent projects.
• Develop integrated project plans covering technical, quality, regulatory, supply chain, and operational work streams.
• Drive project reviews, risk management, stage-gate decisions, and change control.
• Ensure all activities comply with Good Manufacturing Practices, regulatory, and CDMO client expectations.
• Manage expectations, provide regular status updates, and ensure transparency of risks and milestones.
• Manage site capital expenditure budgets, forecasts, and cost tracking.
• Support regulatory submissions, client audits, and authority inspections as required.
• Identify risks, bottlenecks, and process inefficiencies within the project portfolio and drive mitigation plans.
• Manage cross-functional teams and set expectations based on project timelines.
• Lead internal and external project team meetings, facilitate decision-making, and drive execution to ensure key milestones and deliverables are achieved.
• Foster accountability by monitoring progress, communicating expectations, and ensuring timely completion of assigned deliverables.
• Other duties as assigned.

• Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related field (advanced degree preferred).
• 5+ years of experience in pharmaceutical manufacturing, biotech, or CDMO operations.
• Proven experience managing complex technical projects in a Good Manufacturing Practices environment.
• Deep understanding of drug development, technology transfer, validation, and commercial manufacturing.
• Strong financial acumen, including budget management and commercial awareness.
• Excellent communication, stakeholder management, and negotiation skills.

• Formal project management training (Project Management Professional, PRINCE2, Agile) is an advantage.

The final salary offered to a successful candidate may vary within this range $85,000 – $115,000, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a global employer, and this salary range does not reflect positions that work in other countries.

• Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance)
• Group Retirement Savings – Registered Pension Plan (RPP) with employer contributions
• Employee…