Regulatory Affairs Talent Pool in Ireland, Scotland at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Affairs Talent Pool based in Ireland.

This opportunity is designed for experienced regulatory affairs professionals who are passionate about supporting the development and approval of innovative healthcare solutions that improve patient outcomes worldwide. As part of a dynamic talent community, you will have the chance to contribute across a broad range of regulatory disciplines, helping organizations navigate complex global requirements throughout the product lifecycle. The role offers exposure to diverse therapeutic areas, international regulatory environments, and cross-functional collaboration with experts across clinical development, quality, manufacturing, and market access. Whether your expertise lies in regulatory strategy, submissions, labeling, operations, or health authority interactions, this opportunity provides a flexible and impactful environment where your knowledge can help bring life-changing therapies to patients around the world.

• Support the development and execution of regulatory strategies to facilitate successful product development, registration, and lifecycle management activities.
• Prepare, review, coordinate, and manage regulatory submissions and documentation in compliance with regional and global regulatory requirements.
• Contribute to labeling development, maintenance, and compliance activities, ensuring product information remains accurate and aligned with regulatory standards.
• Provide regulatory guidance for advertising, promotional materials, and external communications to ensure compliance with applicable regulations.
• Support Chemistry, Manufacturing, and Controls (CMC) activities by contributing regulatory expertise throughout product development and manufacturing processes.
• Collaborate with health authorities and regulatory agencies, supporting responses, communications, submissions, and approval processes.
• Manage regulatory operations activities, including submission publishing, document management, tracking, and compliance oversight.
• Partner with cross-functional teams to ensure regulatory considerations are integrated into development, commercialization, and post-approval activities.
• Monitor regulatory changes, emerging guidelines, and industry trends to proactively assess potential impacts and opportunities.

• Bachelor's degree or higher in Life Sciences, Pharmacy, Chemistry, Biotechnology, Regulatory Affairs, or a related scientific discipline.
• Professional experience in regulatory affairs within the pharmaceutical, biotechnology, medical device, healthcare, or life sciences sectors.
• Expertise in one or more regulatory disciplines, including regulatory strategy, labeling, regulatory operations, publishing, CMC, advertising and promotion, or health authority interactions.
• Strong understanding of regional and global regulatory frameworks and submission requirements.
• Experience preparing, reviewing, and managing regulatory documentation and submissions.
• Knowledge of regulatory processes throughout the product development and lifecycle management stages.
• Excellent organizational skills with the ability to manage multiple projects and deadlines simultaneously.
• Strong analytical thinking, attention to detail, and problem-solving capabilities.
• Effective communication and stakeholder management skills with the ability to work across multidisciplinary teams.
• Ability to thrive in a collaborative, fast-paced, and highly regulated environment.
• Proficiency in English, with additional language skills considered an advantage depending on regional responsibilities.

• Remote work opportunities offering flexibility and improved work-life balance.
• Exposure to diverse regulatory projects across multiple therapeutic areas and global markets.
• Opportunity to contribute to the development and approval of innovative healthcare products.
• Collaborative and mission-driven environment focused on improving patient outcomes worldwide.
• Access to professional development opportunities and ongoing learning within the regulatory field.
• Cross-functional collaboration with experts across clinical development, regulatory, quality, manufacturing, and market access functions.
• Potential career growth opportunities across multiple regulatory specializations and global programs.
• Meaningful work supporting the advancement of therapies that positively impact patients' lives.