Global Regulatory Affairs Manager-Maternity Cover

IQVIA Italia; Parma; In loco; EUR 46.000 - 57.000; Tempo pieno

Descrizione del lavoro

IQVIA on behalf of Chiesi Farmaceutici seeks a Global Regulatory Affairs Manager to join our international team for a fixed-term maternity cover. Based in Italy, you will partner with GRL and GRT to shape regulatory strategies across EU and global markets.

The role requires 3–4 years in international regulatory affairs, with preferred experience in rare diseases. You will shepherd HA interactions, author regulatory documents, and ensure timely submissions while maintaining compliance.

Competenze

• 3–4 years' experience in International Regulatory Affairs.
• Experience in regulatory affairs within rare diseases is preferred.
• Proficient in regulatory submissions and lifecycle management.

Mansioni

• Serve as regional/local regulatory lead and HA contact.
• Contribute (independently or with GRL guidance) to global HA interaction strategy.
• Develop and manage health authority engagement plans for assigned products incl. authoring meetings.
• Communicate/track interactions with HAs for projects in remit.
• Lead regulatory sub-team to meet NDA/MAA/Extensions/Variations timelines and develop core global dossier.
• Ensure regulatory submission timelines align with program objectives.
• Contribute to content and reviews for regulated documents.
• Support GMP, GCP, and GPV inspections from health authorities.
• Provide updates on project and submissions status at GRT meetings.
• Support GRL on updates to Affiliates and interactions with IMDD and partners.

Conoscenze

International Regulatory Affairs

Regulatory strategy

HA interaction

Veeva Vault

Strumenti

Veeva Vault

Descrizione del lavoro

On behalf of our Client, Chiesi Farmaceutici, one of the top 50 pharmaceutical companies in the world with more than 80 years of experience in the pharmaceutical and biotechnology industry, IQVIA is looking for a Global Regulatory Affairs Manager (fixed-term maternity cover) to join an exciting working environment in a dynamic and international atmosphere.

Purpose:

As core member of the GRT and strategic partner of the GRL, leverages their regulatory expertise to contribute to the definition and drive the execution of aligned EU, extra-EU and/or global regulatory strategy working flexibly within and across regions to ensure the delivery of business objectives.

Supports development and/or execution of Global Regulatory Strategy to support the TPP.

Ensures alignment of TPP to core product labelling for development/lifecycle management for the assigned region(s).

Main Responsibilities:

• May serve as a regional/local regulatory lead and point of contact both internally and with Health Authorities;
• May contribute (independently or with GRL guidance) to the development of global HA interaction strategy in collaboration with GRT;
• Accountable for developing, independently or with GRL guidance, the Health Authority engagement and interaction plans for their assigned products incl. authoring, leading and moderating preparation meetings;
• Accountable for complete and accurate communication/interaction (including tracking) with the relevant HAs for the projects/products in their remit;
• Leads, independently or with GRL guidance, regulatory sub team to ensure NDA/MAA/Extensions/Variations filings meet the project timelines, develop core global dossier, and collaborates with other GRT members as appropriate;
• Ensures that regulatory submission timelines are aligned with program level and company objectives;
• Contributes to content and reviews for regulated documents;
• Supports operational and compliance activities for assigned deliverables, HA contact report (EU & EXTRA-EU);
• Supports GMP, GCP, and GPV inspections from health authorities;
• Accountable to provide updates on project and submissions status at GRT meetings;
• Accountable to support the GRL on updates to the Affiliates and interactions with IMDD and partners.

Experience Required:

• Around 3-4 years' experience in International Regulatory Affairs;
• Experience in regulatory affairs within rare diseases is preferred.

Education:

Languages:

Technical Skills:

• Emerging understanding of clinical development of drugs and/or novel biologics products;
• Understanding of LCM activities (strategy and executions EU/major extra-EU countries);
• Ability to work in electronic document management systems, such as Veeva Vault;
• Demonstrated ability to handle multiple projects/deliverables simultaneously is preferred ;
• Strong sensitivity for a multicultural/multinational environment ;
• Data readiness & competitive intelligence ;

Soft Skills:

• Stress management;
• Time management;
• Planning and organizational skills;
• Strategic thinking.

Type of contract:

National Collective Labour Agreement: Chemical and Pharmaceutical Industry;

Contract Type: Fixed Term-temporary position covering maternity leave;

Salary Range or Gross Annual Salary: from 46.000€ to 57.000€ RAL.

The salary range is defined based on experience, skills, and internal equity criteria. Career progression and compensation review are based on transparent, objective criteria. We are committed to fair and equal pay practices, in line with applicable pay transparency regulations (EU Directive 2023/970).

IQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request. Applications WITHOUT the requirements Will NOT be fully taken into account. Please enter the authorization for the processing of personal data (DL196/2003) - General Data Protection Regulation (13 GDPR 679/16 –) to IQVIA and to transfer those data to IQVIA’s Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).