Manager, EU & International Regulatory Affairs (Global Rare Diseases)

TL;DR

Manager, EU & International Regulatory Affairs (Global Rare Diseases): Developing regulatory strategies for EU and international markets to support the commercialization of treatments for rare diseases with an accent on regulatory submissions and agency coordination. Focus on managing the product life cycle, ensuring documentation quality, and negotiating strategies with regional regulatory authorities.

Location: Must be based in or be able to relocate to Parma, Italy or Dublin, Ireland

Salary: Minimum €46,800 (package applied for Italy)

Company

hirify.global is an international research-focused biopharmaceutical group dedicated to developing innovative drugs and treatments for a healthier world.

What you will do

• Develop regulatory strategies for EU & International markets to meet Global Rare Diseases objectives.
• Plan, coordinate, and manage regulatory submissions to regional agencies throughout the product life cycle.
• Provide guidance on regional regulatory requirements to drive geographical expansion of products.
• Communicate and negotiate strategies and actions directly with regional regulatory authorities.
• Review regulatory submission documents and periodic updates to ensure high quality and adequacy.
• Contribute to the development of Standard Operating Documents and provide expertise for due diligence assessments.

Requirements

• 3 to 5 years of experience in corporate regulatory affairs with in-depth knowledge of drug development.
• Degree in Life Sciences.
• Strong written and oral communication and listening skills.
• Ability to manage complex assignments and work independently or as part of a team.
• Must be based in or be able to relocate to Italy (Parma) or Ireland (Dublin).

Nice to have

• Experience in leadership and coaching.

Culture & Benefits

• Competitive salary package with an annual bonus scheme.
• Comprehensive benefits including pension, private medical insurance, and wellbeing programs.
• Flexible working arrangements and remote work options.
• Robust relocation support and tax assistance services for foreign colleagues.
• Environment focused on diversity, inclusion, and sustainable innovation.