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Regulatory Affairs Specialist, Labeling

2 mesi fa

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

Chiesi Group is a leading international pharmaceutical and healthcare company with a rich history of innovation and commitment to improving people's quality of life. With over 85 years of experience, we operate in 31 countries and employ over 7,000 dedicated professionals.

Our Mission

We strive to achieve our mission by researching, developing, and marketing innovative drugs in our main therapeutic areas. Our goal is to make a positive impact on people's lives while acting responsibly towards society and the environment.

Our Values

We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, recognizing our high social and environmental standards. We value transparency, ethics, and diversity, and we believe that our people are our most valuable asset.

Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist, Labeling to join our team. The successful candidate will be responsible for overseeing RIMS reporting for the GRD portfolio, supporting the Manager, Compliance, RA in preparation for inspections, and evaluating local labels and conducting gap analyses.

Key Responsibilities
  • Oversee RIMS reporting for the GRD portfolio by entering RIMS data, coordinating RIMS reporting by teammates, and supporting GRDRA in developing systems and processes for maintaining complete and accurate RIMS records.
  • Support the Manager, Compliance, RA in the preparation for inspections and inspection readiness.
  • Evaluate local labels and conduct gap analyses between local labels and the CCDS.
  • Legalize documents in support of various international submissions on behalf of GRDRA as assigned.
Requirements
  • 2+ years' experience in Regulatory Affairs, preferably with exposure to international regulatory jurisdictions.
  • Degree in an appropriate life science field, e.g., Pharmacology, Biological Sciences, Chemistry, Analytical Sciences, Pharmacy, or Medicine, or in an IT system field.
  • Fluent in English.
What We Offer

We offer a dynamic, fast-growing, and challenging work environment. We invest in continuous training, learning, and development, and we strive to promote and satisfy development needs. We prioritize the quality of our working environment and collective well-being, and we offer flexible working approaches, remote working, and support in the relocation process.