Global Regulatory Affairs Manager: Strategy & Compliance

Regulatory Pharma Net - RPN; Lombardia; On-site; EUR 40,000 - 45,000; Full time

Benefits offered by this job

Birthday leave

Buddy program

Job summary

Regulatory Pharma Net - RPN is seeking a Regulatory Affairs Manager to join our Regulatory Affairs Team in Lombardia. You will lead regulatory strategies, coordinate submissions, and guide clients through EU and international requirements.

The role emphasizes cross-functional collaboration, timely deliverables, and a risk-based approach to regulatory decisions. A Master’s degree and at least five years in Regulatory Affairs are required.

Qualifications

• Master’s degree in Pharmaceutical Chemistry and Technology, Pharmacy, or related field.
• At least 5 years of experience in Regulatory Affairs in the pharmaceutical sector.
• Strong knowledge of EU and international regulatory frameworks (EMA, FDA, ICH).
• Excellent command of English, both written and spoken.
• Strong project management, communication, and team-oriented mindset.

Responsibilities

• Strategic Regulatory activities: define global/regional regulatory strategies and identify optimal registration pathways.
• Prepare, review, and oversee regulatory documentation for MAA including CTD Modules.
• Ensure accuracy, completeness, and consistency of regulatory submissions.
• Plan and manage regulatory procedures (MAA, variations, line extensions, renewals) across EU and non-EU markets.
• Provide regulatory support to clinical development and CMC projects.
• Coordinate multidisciplinary teams and manage timelines to ensure high-quality deliverables.

Skills

Regulatory strategy

Regulatory submissions

Project management

Communication

English proficiency

Team collaboration

Education

Master's degree in Pharmaceutical Chemistry and Technology / Pharmacy

Job description

Regulatory Pharma Net - RPN is seeking a Regulatory Affairs Manager to join our Regulatory Affairs Team in Lombardia. You will lead regulatory strategies, coordinate submissions, and guide clients through EU and international requirements.

The role emphasizes cross-functional collaboration, timely deliverables, and a risk-based approach to regulatory decisions. A Master’s degree and at least five years in Regulatory Affairs are required.