Regulatory Affairs Specialist
3 settimane fa
About Us
Chiesi is a global, research-driven pharmaceutical and healthcare organization with a legacy of over 85 years, operating across 31 countries and employing more than 7,000 individuals. Our mission is to enhance the quality of life for individuals while maintaining a responsible approach towards society and the environment. We focus on the research, development, and marketing of innovative pharmaceuticals in key therapeutic areas.
We take pride in being the largest global pharmaceutical entity to achieve B Corp Certification, which signifies our commitment to high social and environmental standards. Our company is dedicated to transparency and ethical conduct at all levels.
At Chiesi, we believe that our success is shaped by our workforce and our shared values. It is essential for us to attract and retain talent that will contribute positively to our culture.
We are committed to diversity, inclusion, and equal opportunities. Our global family comprises individuals from various cultures, genders, generations, ethnicities, abilities, and sexual identities.
Chiesi Global Rare Diseases
Established in February 2020, Chiesi Global Rare Diseases is a dedicated unit within the Chiesi Group, focusing on the research, development, and commercialization of treatments and support services for rare and ultra-rare conditions, many of which lack available therapies.
Headquartered in Boston, Massachusetts, this unit prioritizes research and product development for lysosomal storage diseases, rare hematology, and ophthalmology disorders, collaborating with global leaders in scientific research and patient advocacy.
PurposeThe primary aim is to manage and oversee regulatory information and documentation related to GRDRA within RIMS and eDMS, while supporting labeling activities and GRDRA processes.
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 and processes to maintain 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 by extracting data from RIMS
- Assist the Compliance Manager in preparing for inspections and ensuring inspection readiness.
- Support Regulatory Affairs in the preparation, updating, and maintenance of core data sheets and local labeling.
- Analyze local labels and perform gap assessments against the CCDS.
- Legalize documents for various international submissions as required.
- Ensure all tasks are performed in compliance with established regulatory and safety standards.
Minimum of 2 years of experience in Regulatory Affairs, preferably with exposure to international regulatory environments.
EducationA degree in a relevant life science field such as Pharmacology, Biological Sciences, Chemistry, Analytical Sciences, Pharmacy, or Medicine, or in an IT systems field.
LanguagesFluency in English is required.
Technical Skills- Proficient in RIMS and document management systems.
- Familiarity with eCTD structure and ability to identify and assess gaps in regulatory information.
- Understanding of drug development stages and regulatory lifecycle management.
- Ability to work collaboratively in a geographically diverse 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 interaction with staff at all levels.
- Proficient in MS Office, Adobe Acrobat, RIMS, and eDMS.
- Strong planning and organizational abilities
- Team collaboration
- Excellent communication skills
What We Offer
Joining Chiesi means becoming part of a dynamic, fast-paced, and supportive environment. We recognize that our employees are our greatest asset, which is why we invest in ongoing training and development. We are dedicated to fostering a high-quality work environment and promoting collective well-being.
We strive to ensure our employees find joy in their work and understand the importance of achieving a healthy work-life balance. Our offerings include flexible working arrangements, remote work options, assistance with relocation, tax support for international colleagues, and various employee care services.
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