Labelling Compliance Expert

3 settimane fa

Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

About Us

Chiesi is a globally recognized pharmaceutical and healthcare organization headquartered in Parma, Italy, with a legacy of over 85 years. Operating across 31 countries, we are committed to enhancing the quality of life for individuals while maintaining a strong focus on social responsibility and environmental stewardship. Our innovative approach to drug development spans several therapeutic areas, and we take pride in being the largest global pharmaceutical entity to receive B Corp Certification, a testament to our adherence to high social and environmental standards.

At Chiesi, we believe that our success is deeply rooted in our people and the shared values that guide us. We strive to attract and retain talented individuals who contribute to our culture and embody our core values.

We are dedicated to fostering diversity, inclusion, and equal opportunities within our workforce, creating a global family enriched by various cultures, genders, generations, ethnicities, abilities, and identities.

Chiesi Global Rare Diseases

Established in February 2020, Chiesi Global Rare Diseases is a specialized unit within the Chiesi Group focused on the research, development, and commercialization of treatments for rare and ultra-rare disorders. This unit is headquartered in Boston, Massachusetts, and is committed to addressing the needs of patients with limited or no treatment options.

Purpose

The primary objective of this role is to manage and oversee regulatory information and documentation related to GRDRA, ensuring compliance with established processes and supporting labelling activities.

Main Responsibilities
  • Manage RIMS reporting for the GRD portfolio by:
    • inputting data into RIMS
    • coordinating reporting efforts among team members
    • assisting GRDRA in developing systems for maintaining accurate RIMS records
    • training colleagues and serving as an internal resource
    • designing and conducting quality checks on RIMS data for consistency and accuracy
    • calculating and reporting KPIs as required
  • Assist the Compliance Manager in preparing for inspections and ensuring inspection readiness.
  • Support the Regulatory Affairs team in updating and maintaining core data sheets and local labelling.
  • Analyze local labels and identify gaps compared to the CCDS.
  • Legalize documents for various international submissions as needed.
  • Ensure all tasks are performed in accordance with regulatory, compliance, and safety standards.
Experience Required

A minimum of 2 years of experience in Regulatory Affairs, preferably with exposure to international regulatory environments.

Education

A degree in a relevant life science field, such as Pharmacology, Biological Sciences, Chemistry, Analytical Sciences, Pharmacy, or Medicine, or in an IT-related field.

Languages

Fluency in English is required.

Technical Skills
  • Proficient in RIMS and document management systems.
  • Familiarity with eCTD structure and the ability to identify gaps in regulatory information.
  • Understanding of drug development stages and regulatory lifecycle management.
  • Ability to work collaboratively in a geographically distributed team.
  • Skilled in organizing and leading meetings, facilitating discussions, and preparing minutes.
  • Highly organized with the ability to manage personal deliverables and coordinate with teammates.
  • Effective communication skills at all organizational levels.
  • Proficient in MS Office, Adobe Acrobat, RIMS, and eDMS.
Soft Skills
  • Strong planning and organizational abilities
  • Team collaboration
  • Excellent communication skills

What We Offer

Joining Chiesi means becoming part of a dynamic and supportive environment. We recognize that our employees are our greatest asset, which is why we invest in continuous training and development. We prioritize the quality of our work environment and the well-being of our team members. Our flexible working arrangements, remote work options, and various employee support services are designed to help maintain a healthy work-life balance.

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