[Hiring] Specialist Care Therapeutic Area, Global Regulatory Affairs and Patient Safety @Chiesi Group

Role Description

We are looking for a motivated regulatory affairs professional to join our Global Regulatory and Patient Safety team on a temporary contract (maternity leave replacement).

As core member of the GRT and strategic partner of the GRL, the incumbent leverages personal regulatory expertise to contribute to the definition and drive the execution of aligned global regulatory strategy. They work flexibly within and across regions (mainly Europe) to ensure the delivery of business objectives and support the development and/or execution of Global Regulatory Strategy to ensure that TPP is aligned to core product labelling for development/lifecycle management for the assigned region(s).

You will be responsible for:

• May serve as a regional/local regulatory lead and point of contact both internally and with competent national authorities in EU countries and EMA.
• Contribute (independently or with GRL/Manager guidance) to the development of global HA interaction strategy in collaboration with GRT members.
• Accountable for developing, singly or with GRL guidance/Manager support, the HA engagement & interaction plans for assigned products incl. authoring, leading & moderating preparation meetings.
• Accountable for complete and accurate communication/interaction (including tracking in relevant systems) with the HAs, affiliates and IMDD partners for the projects/products in their remit.
• Lead, independently or with GRL guidance, regulatory subteam to ensure NDA/BLA/MAA/Extensions/Variations/Renewals filings meet the project timelines.
• Collaborate with Project Manager to develop core global dossier and collaborate with other GRT members as appropriate.
• Ensure regulatory submission timelines are aligned with program level and company objectives.
• Contribute to content and reviews for regulated documents.
• Support operational and compliance activities for assigned deliverables.
• Support GMP, GCP, and GPV inspections from health authorities.
• Accountable to provide updates on project and submissions status to GRT members.
• Accountable to support the GRL on updates to the Affiliates and interactions with IMDD and partners.

Qualifications

• Experience in regulatory lifecycle management in Europe, particularly with MRP/DCP and centralized procedures.
• Fluent English.
• Excellent attention to detail, including data consistency, traceability, and alignment across submission documents.
• Ability to solve problems proactively and problem solving skills and the ability to work both independently and collaboratively in multidisciplinary team.

Requirements

• Fluent English.

Benefits

• Comprehensive healthcare programs.
• Work-life balance initiatives.
• Robust relocation support.
• Competitive salary package, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market.
• Flexible working arrangements and remote work options.
• Tax assistance services for foreign colleagues.