Regulatory Affairs Manager

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 nonEU markets.

Crossfunctional & Project Management activities:

• 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 riskbenefit approach.

WHAT ARE THE REQUIREMENTS

• Masters degree in Pharmaceutical Chemistry and Technology Pharmacy or related scientific fields.
• At least 8 of experience in Regulatory Affairs within the pharmaceutical sector.
• Strong knowledge of EU and international regulatory frameworks (EMA FDA ICH) with experience managing multicountry 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.

Contract details:

• Type: Permanent
• Location: Milan
• 23 remote work days/week

Benefits:

• 10 meal voucher per on-site working day
• Competitive corporate welfare plan
• Birthday leave

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.