Line Manager / Regulatory Affairs Manager Ireland

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

What to Expect

• Line management, training of Regulatory Specialist
• Training of the direct reports in EMEA / FDA requirements
• Establish and manage regulatory submission timelines for both new and existing products across key global markets
• Engage with regulatory authorities and distribution partners to support product registrations
• Conduct global regulatory impact assessments for product and manufacturing changes through the document control process; prepare and submit required regulatory updates.
• Act as the regulatory representative on cross‑functional teams, collaborating with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.
• Interpret and apply international regulations, standards, and directives to ensure ongoing global compliance
• Support and participate in inspections and audits conducted by global regulatory authorities.

Requirements

• Min 8 years in regulatory affairs
• Min 4 years as Regulatory Affairs Manager
• Experience with EMEA / FDA regulatory requirements
• Ideally line management of a team
• Excellent written and verbal in English
• Availability to work 4 days in the office

If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email [e-mail]