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 Affairs Manager at Regulatory Pharma Net - RPN will lead strategic regulatory activities and oversee MAAs, ensuring submissions meet EU and international standards. You will coordinate timelines, support CMC projects, and guide clients on regulatory risks.

The role requires 5+ years in Regulatory Affairs, a Master’s in a related field, and strong English skills. It offers permanent employment in Milano with a buddy onboarding and birthday leave benefits.

Competenze

• Master's degree in Pharmaceutical Chemistry and Technology, Pharmacy, or related scientific fields.
• Minimum 5 years of experience in Regulatory Affairs within the pharmaceutical sector.
• Strong knowledge of EU and international regulatory frameworks (EMA, FDA, ICH).

Mansioni

• Define regulatory strategies and oversee MAA documentation, including CTD Modules.
• Ensure accuracy, completeness, and consistency of regulatory submissions.
• Plan and manage regulatory procedures across EU and non-EU markets.
• Provide regulatory support to clinical development and CMC projects.
• Coordinate multidisciplinary teams and manage timelines.
• Support clients in regulatory decision-making via risk–benefit approach.

Conoscenze

English

Project management

Communication

Teamwork

Formazione

Master's degree in Pharmaceutical Chemistry and Technology, Pharmacy, or related scientific fields

Descrizione del lavoro

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.