Regulatory Affairs Talent Pool

Overview

This opportunity is offered through a partner employer, which handles the application review and all subsequent hiring steps. The hiring team is building a regulatory affairs talent community in Ireland for seasoned professionals who want to help advance healthcare products that can improve patient outcomes globally.

The role provides exposure to a wide range of regulatory work across multiple therapeutic areas and international markets. It is suited to professionals who enjoy working with cross-functional teams and contributing to every stage of the product journey, from development and submission through approval and post-approval maintenance. Depending on your background, you may bring strength in regulatory strategy, submissions, labeling, operations, CMC, or interactions with health authorities.

Key Accountabilities

• Help shape and deliver regulatory plans that support product development, registration, and ongoing lifecycle activities.
• Draft, check, coordinate, and oversee regulatory filings and supporting documentation in line with local, regional, and global rules.
• Assist with labeling work, including development, updates, and compliance reviews to keep product information accurate and aligned with regulatory standards.
• Offer regulatory input on promotional content, advertising, and outward-facing communications so they remain compliant.
• Contribute regulatory expertise to CMC-related work across product development and manufacturing.
• Work with health authorities and regulatory bodies on submissions, correspondence, responses, and approval-related activities.
• Handle regulatory operations tasks such as publishing submissions, managing documents, tracking progress, and maintaining compliance controls.
• Partner with teams across development, commercialization, and post-approval functions to ensure regulatory requirements are addressed throughout the product lifecycle.
• Keep track of changing regulations, new guidance, and industry developments to identify risks and opportunities early.

Requirements

• A bachelor’s degree or higher in Life Sciences, Pharmacy, Chemistry, Biotechnology, Regulatory Affairs, or a closely related scientific field.
• Prior professional experience in regulatory affairs within pharmaceuticals, biotechnology, medical devices, healthcare, or broader life sciences settings.
• Practical knowledge in one or more areas such as regulatory strategy, labeling, operations, publishing, CMC, advertising and promotion, or interactions with health authorities.
• Solid understanding of regional and international regulatory frameworks and submission expectations.
• Hands-on experience preparing, reviewing, and managing regulatory documents and filings.
• Working knowledge of regulatory requirements across development and lifecycle management stages.
• Strong planning and coordination skills, with the ability to manage several projects and deadlines at once.
• Excellent analytical ability, careful attention to detail, and a structured approach to solving problems.
• Good communication and stakeholder management skills, with the ability to work effectively across multidisciplinary groups.
• Comfort working in a collaborative, fast-moving, and highly regulated environment.
• Strong English proficiency; additional language ability may be helpful depending on the region covered.

Benefits

• Flexible remote working that supports better work-life balance.
• Exposure to varied regulatory initiatives across several therapeutic areas and global markets.
• The chance to help bring innovative healthcare solutions through the approval process.
• A collaborative, purpose-driven environment centered on improving patient outcomes worldwide.
• Opportunities for ongoing learning and professional growth in regulatory affairs.
• Close collaboration with specialists in clinical development, quality, manufacturing, regulatory, and market access.
• Potential for career progression across different regulatory specialties and international programs.
• Work that contributes meaningfully to therapies that can positively affect patients’ lives.

Application and Data Information

This hiring process uses an AI-assisted matching approach to evaluate applications quickly, consistently, and fairly against the main job criteria. Shortlisted candidates are passed to the employer for next steps, while interviews and assessments are handled by the hiring company’s own team.

By applying, you consent to the processing of your personal data for candidate evaluation and sharing relevant details with the employer, based on legitimate interest and pre-contractual steps under applicable data protection laws, including GDPR. You may exercise your rights to access, correct, delete, or object to processing at any time.

AI tools may support parts of recruitment, such as application review, resume analysis, or response assessment, but human decision-making remains central to the final hiring outcome.