Strategic Global Regulatory Affairs Manager

Regulatory Pharma Net - RPN; Milano; In loco; EUR 40.000 - 45.000; Tempo pieno

Vantaggi offerti da questo lavoro

Birthday leave

Buddy program

Descrizione del lavoro

Regulatory Pharma Net - RPN seeks a Regulatory Affairs Manager to lead regulatory strategy and submissions for global markets. You will oversee CTD documentation, coordinate cross-functional teams, and advise clients on regulatory requirements across EU and international frameworks.

The role emphasizes collaboration with clinical development and CMC projects, ensuring timely, compliant deliverables and effective stakeholder communication in a dynamic environment.

Competenze

• Master’s degree in Pharmaceutical Chemistry and Technology, Pharmacy, or related field.
• At least 5 years of experience in Regulatory Affairs within the pharmaceutical sector.
• Strong knowledge of EU/international regulatory frameworks (EMA, FDA, ICH).
• Excellent command of English, written and spoken.
• Proven ability to manage multi-country projects and coordinate stakeholders.
• CCNL Commercial Sector.
• Type of contract: permanent.
• Salary range (RAL): €40,000 – €45,000.

Mansioni

• Preparing, reviewing, and overseeing regulatory documentation for MAA, including CTD Modules.
• Ensuring accuracy, completeness, and consistency of regulatory submissions, in line with guidelines.
• Planning, coordinating, and managing regulatory procedures across EU and non-EU markets.
• Providing regulatory support to clinical development and CMC projects.
• Coordinating multidisciplinary teams and managing timelines to ensure high-quality deliverables.

Conoscenze

Regulatory knowledge

Project management

Communication

Team coordination

English

Formazione

Master’s degree in Pharmaceutical Chemistry and Technology, Pharmacy, or related field

Descrizione del lavoro

Regulatory Pharma Net - RPN seeks a Regulatory Affairs Manager to lead regulatory strategy and submissions for global markets. You will oversee CTD documentation, coordinate cross-functional teams, and advise clients on regulatory requirements across EU and international frameworks.

The role emphasizes collaboration with clinical development and CMC projects, ensuring timely, compliant deliverables and effective stakeholder communication in a dynamic environment.