Senior Regulatory Affairs Officer

​Senior Regulatory Affairs Officer

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Location: Dublin (Hybrid / Office-Based)

Industry: Pharmaceutical

Contract Type: Permanent

Salary: Competitive base salary + performance-related bonus + benefits

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Overview

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Gray Wave Recruitment is seeking an experienced Senior Regulatory Affairs Officer on behalf of a rapidly expanding pharmaceutical group with strong operations across Ireland, the UK and international markets. This is an excellent opportunity to join a company with a diverse portfolio of OTC and prescription medicines, working within a collaborative regulatory team that supports ongoing product growth and compliance.

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Key Responsibilities

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• Ensure all company products remain compliant with relevant regulatory standards and legislation across multiple territories.

• Prepare and submit Type IA, IB, and II Variations in accordance with EU and international requirements.

• Manage license transfers and related documentation for various international markets.

• Review and approve promotional materials for medicinal products in line with regulatory guidelines.

• Prepare Module 1 documentation for National Applications and assist with submissions.

• Represent the company during meetings with Regulatory Authorities, ensuring timely responses to queries.

• Support the internationalisation and reclassification of existing products.

• Mentor and train junior regulatory team members on procedures and compliance standards.

• Monitor, interpret, and communicate regulatory updates and trends impacting the business and its markets.

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Candidate Profile

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• Minimum 3 - 4 years’ experience in a Regulatory Affairs role within the pharmaceutical or related healthcare industry.

• Strong working knowledge of MRP, DCP and CP procedures.

• Experience with medical device regulations is highly desirable.

• Excellent organisational and communication skills, with a high level of accuracy and attention to detail.

• Capable of managing multiple projects simultaneously under time constraints.

• Proactive, self-driven and comfortable taking ownership of responsibilities.

• Resilient and adaptable, with a results-oriented mindset.

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What’s on Offer

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• A chance to join an expanding pharmaceutical group with a strong market presence across multiple regions.

• Exposure to both OTC and prescription portfolios within a highly regulated environment.

• Opportunities to develop leadership and mentoring skills within a growing regulatory team.

• Competitive salary and benefits, aligned with experience and contribution.

• A collaborative, supportive working culture with clear career progression pathways.

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Interested?

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If you’re a motivated Regulatory Affairs professional who takes pride in accuracy, compliance and driving product excellence - and you’re seeking to advance your career in a growing, international pharmaceutical environment - we’d love to hear from you.

Apply now with Grey Wave Recruitment, or contact our team for a confidential discussion about this opportunity.