Global Regulatory Affairs Manager - Line Lead & Compliance

Resourcing Life Science; Ireland; On-site; EUR 70,000 - 90,000; Full time

Job summary

A leading life sciences company is seeking an experienced Regulatory Affairs Manager in Ireland. You will manage a team and be responsible for compliance with EMEA and FDA requirements. The ideal candidate has over 8 years of experience in regulatory affairs and strong leadership skills. You will engage with regulatory authorities, manage submission timelines, and interpret international regulations. This role requires excellent communication in English and availability to work 4 days in the office.

Qualifications

• Minimum 8 years in regulatory affairs is required.
• At least 4 years as a Regulatory Affairs Manager.
• Experience with EMEA and FDA regulatory requirements.

Responsibilities

• Manage and train Regulatory Specialists.
• Establish regulatory submission timelines.
• Engage with regulatory authorities for product registrations.
• Conduct regulatory impact assessments for product changes.

Skills

Regulatory Affairs

Team Management

EMEA / FDA Regulations

English Communication

Job description

A leading life sciences company is seeking an experienced Regulatory Affairs Manager in Ireland. You will manage a team and be responsible for compliance with EMEA and FDA requirements. The ideal candidate has over 8 years of experience in regulatory affairs and strong leadership skills. You will engage with regulatory authorities, manage submission timelines, and interpret international regulations. This role requires excellent communication in English and availability to work 4 days in the office.