Regulatory Affairs Manager

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

We are looking for a Regulatory Affairs Manager to join our Regulatory Affairs Team.

WHAT WILL YOU DEAL WITH?

Strategic Regulatory activities:

• Supporting the definition of global and regional regulatory strategies, identifying optimal registration pathways based on product characteristics, development stage and target markets.
• Providing strategic guidance to clients on regulatory requirements and potential risks, ensuring compliance with EU and international frameworks.

Regulatory Affairs activities:

• Preparing, reviewing, and overseeing regulatory documentation for Marketing Authorization Applications (MAA), including CTD Modules.
• Ensuring accuracy, completeness, and consistency of regulatory submissions, in line with international guidelines and client requirements.
• Planning, coordinating, and managing regulatory procedures (e.g. MAA, variations, line extensions, renewals) across EU and non-EU markets.
• Providing regulatory support to clinical development and CMC projects, ensuring alignment with overall development plans.
• Coordinating multidisciplinary teams and managing timelines to ensure high-quality deliverables and compliance with deadlines.
• Supporting clients in regulatory decision-making through a risk-benefit approach.

WHAT ARE THE REQUIREMENTS?

• Master’s degree in Pharmaceutical Chemistry and Technology, Pharmacy, or related scientific fields.
• At least 5 of experience in Regulatory Affairs within the pharmaceutical sector.
• Strong knowledge of EU and international regulatory frameworks (EMA, FDA, ICH), with experience managing multi-country projects.
• Excellent command of English, both written and spoken.
• Strong project management skills, excellent communication abilities, and a team oriented mindset, with the capacity to coordinate complex projects, facilitate stakeholder dialogue, and collaborate effectively within multidisciplinary teams.
• CCNL Commercial Sector
• Type of contract: permanent
• Salary range (RAL): €40,000 - €45,000. The actual compensation offered may vary based on several factors, including job-related qualifications such as knowledge, skills, education, experience, and location.
• Birthday leave
• Buddy program for onboarding: from day one, you’ll be supported by a dedicated contact to help you settle in and integrate with the team

The selection, respects Legislative Decree 198/2006 and is open to candidates of any orientation or expression of gender, sexual orientation, age, ethnicity and religious belief. This announcement is designed to respect diversity and inclusiveness.