Manager, EU & International Regulatory Affairs - Global Rare Diseases

4w4 weeks ago

Chiesi Group

Dublin, IE · Full-time · €46,800 – €46,800

About this role

Chiesi is an international research-focused biopharmaceutical group with 90 years of experience, operating in more than 30 countries. As a Benefit Corporation and certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.

Chiesi Global Rare Diseases is a business unit established in February 2020, focused on research, development, and commercialization of treatments for rare and ultra-rare disorders. This unit is based in Boston, Massachusetts, with strong synergy with the headquarters in Parma, Italy.

Reporting to the Lead, EU & International Regulatory Affairs, Global Rare Diseases, the Manager develops regulatory strategies for EU and international markets. You will collaborate with consultants, partners, and affiliates to plan and manage regulatory submissions throughout the product lifecycle.

You will provide regulatory guidance to colleagues from other functional areas and represent the Regulatory Department at the Core Team. This role offers the opportunity to drive the geographical expansion of innovative therapies for patients with limited or no treatment options.

Requirements

Experience developing regulatory strategies for EU and international markets
Ability to plan, coordinate, and manage regulatory submissions to regional agencies
Knowledge of regional regulatory requirements for rare disease products
Experience communicating directly with regulatory authorities
Skill in critically reviewing regulatory submission documents and making recommendations for improvement
Ability to provide regulatory guidance to cross-functional teams
Experience representing a regulatory department at core team meetings

Responsibilities

Plan, coordinate, and manage regulatory submissions to regional agencies throughout the life cycle of GRD products
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 high quality of documentation
Communicate directly with regional regulatory authorities to negotiate strategies and actions associated with regulatory submissions
Critically review regulatory submission documents, periodic updates, overviews, and summaries, making recommendations for improvement
Contribute to the development of processes and preparation of Standard Operating Documents for GRD Regulatory Affairs
Provide regulatory guidance to colleagues from other functional areas
Provide regulatory expertise in support of due diligence assessments

Benefits

Opportunity to work on treatments for rare and ultra-rare disorders with limited or no available therapies
Part of a global, research-focused biopharmaceutical group with 90 years of experience
Culture of reliability, transparency, and ethical behavior at every level
Diversity and inclusion are at the heart of the company culture
Certified B Corp and Benefit Corporation with sustainability embedded in bylaws