Project Manager II (Pharmaceutical)

TL;DR

Project Manager II (Pharmaceutical): Provide comprehensive leadership, oversight, and execution support for a late-stage pharmaceutical development program entering FDA and EMA registration with an accent on cross-functional coordination across clinical, nonclinical, CMC, regulatory, and manufacturing functions. Focus on managing complex timelines, risks, deliverables, and regulatory submissions to ensure program success.

Location: Milan, Italy

Company

hirify.global is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

What you will do

• Lead planning, execution, and tracking of program activities for regulatory submissions (NDA/MAA), including defining scope, developing plans, schedules, budgets, and managing risks, resources, and changes.
• Coordinate cross-functional teams across clinical operations, nonclinical, pharmaceutical development, regulatory affairs, and manufacturing to ensure alignment on timelines and deliverables.
• Facilitate team meetings, maintain unified timelines, identify interdependencies, and track progress on clinical documents, nonclinical reports, CMC data, and submission modules.
• Provide status updates, issue summaries, and materials for senior leadership, governance committees, and Board reviews while ensuring quality and compliance.
• Liaise with internal teams and external CROs for regulatory strategies, briefing documents, query responses, and integration of content for Modules 1–5.

Requirements

• Bachelor’s degree in Pharmacy, Pharmaceutical Chemistry, Chemistry, Biology, Biochemistry, or related discipline.
• >5 years of project management experience in pharmaceutical/biotech industry with knowledge of GxP, ICH guidelines, and drug development pathways.
• Demonstrated ability to manage cross-functional teams, complex timelines, and excellent proficiency in English (written and oral).
• Experience coordinating clinical operations, regulatory submissions (FDA/EMA), CMC, and nonclinical functions.
• Strong organizational, analytical, problem-solving, leadership, and facilitation skills.

Nice to have

• Advanced scientific or technical degree (MS, PharmD, PhD, MBA).
• Direct experience with registration-phase programs and FDA/EMA submissions.
• PMP or equivalent PM certification.
• Experience with CRO management and global teams.

Culture & Benefits

• Supportive culture focused on quality, professional development, and close management with continuous training.
• Work in a dynamic, fast-paced, high-growth environment with low turnover rates.
• Equal opportunity employer promoting diversity, inclusivity, and talent development.
• Opportunity to work directly for a sponsor while benefiting from global CRO security and career growth.

Hiring process

• Submit CV for acknowledgement.
• Phone interview if requirements match.
• No individual replies for unsuccessful applications due to high volume.