Global Regulatory Affairs Manager - Strategy & Submissions

Regulatory Pharma Net - RPN

Milano

In loco

EUR 40.000 - 45.000

Tempo pieno

14 giorni+

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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.