EU Regulatory Affairs Manager, Rare Diseases

Overview

EU Regulatory Affairs Manager, Rare Diseases — join to apply for the role at Chiesi Group. Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with 90 years’ experience, operating in 31 countries with more than 7,000 employees. The Group researches, develops and markets innovative drugs in its main therapeutic areas.

We are proud to have been awarded with B Corp Certification, recognizing high social and environmental standards. We are a reliable company that adopts and promotes transparent and ethical behavior at all levels. We believe that the success of Chiesi is built and shaped by our people and our shared values and behaviors. We are committed to embrace diversity, inclusion and equal opportunities.

Chiesi Global Rare Diseases is a unit focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders. The unit is based in Boston, MA with strong ties to the Parma headquarters and focuses on lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies.

What we are looking for

Purpose

Develop regulatory strategies for Emerging Markets to meet Chiesi Global Rare Diseases Regulatory Affairs objectives, with regional Head limited supervision.

Main Responsibilities

• In collaboration with consultants, partners and affiliates, plan, coordinate and manage regulatory submissions to regional agencies throughout the life cycle of GRD products
• In full alignment with the regional Head, provide advice and guidance regarding regional regulatory requirements driving the development and geographical expansion of GRD products
• Contribute to the preparation and/or review of submissions to relevant markets to ensure the high quality of the documentation
• In agreement with the regional Head, communicate directly with regional regulatory authorities on behalf of Chiesi GRD to negotiate strategies and actions associated with regulatory submissions
• Critically review regulatory submission documents, periodic updates, overviews, summaries, etc., make recommendations for improvement and ensure adequacy for submission
• Contributes to the development of processes and the preparation of Standard Operating Documents for GRD Regulatory Affairs
• In full alignment with the regional Head, provide regulatory guidance to colleagues from other functional areas
• Provide regulatory expertise in support of due diligence assessments
• Represent the Regulatory Department at the Core Team as a global RA member, where needed
• Support the Regional GRD Regulatory Affairs Head in the preparation of the needed documents for meetings and interactions with regional regulatory authorities

Experience Required

3 to 5 years of experience in corporate regulatory affairs roles with an in-depth knowledge in drug development

Education

Life Science Degrees

Technical Skills

• Experience with European Centralised Procedure and lifecycle management activities
• Exposure to geographical expansion projects

Soft Skills

• Adaptability and flexibility
• Time management
• Leadership and social influence
• Problem solving

What we offer

You would join a dynamic, fast-growing, challenging and friendly environment. We invest in continuous training, learning and development, and promote a high-quality working environment and collective well-being. We offer flexible working arrangements, remote work options, relocation support, tax assistance for foreign colleagues and other people-care services.

We want our people to come to work happy every day and value work-life balance.

Seniority level

• Associate

Employment type

• Full-time

Job function

• Research

Industries

• Pharmaceutical Manufacturing