Qualifications & Experience
- Degree in Life Sciences, Pharmacy, Business, IT, or related discipline
- Demonstrated experience in regulatory submissions or regulatory operations within the pharmaceutical or life sciences industry
- Strong project management and coordination skills
- Excellent attention to detail and ability to manage multiple complex deliverables
- Proficiency with electronic submission systems, dossier structures, and regulatory tools
- For senior levels: proven leadership experience, deep understanding of submission processes, and ability to mentor others
Responsibilities
In this role, you will play a pivotal part in managing the global regulatory submission lifecycle:
- Oversee end-to-end delivery of regulatory submissions for assigned products
- Coordinate cross-functional teams to meet submission timelines and quality expectations
- Manage operational aspects such as planning, document flow, translations, and submission build
- Act as the connection between global, regional, and local teams to align on regulatory requirements
- Drive process optimisation and continuous improvement initiatives
- For senior levels: lead cross-functional strategic projects, represent the organisation in global discussions, and contribute to policy and process development
Skills / Technical Competencies
- Proficiency in submission management systems and electronic publishing tools
- Deep understanding of global regulatory frameworks
- Strong communication and stakeholder engagement across international teams
- Analytical mindset with the ability to work under pressure and deliver to tight deadlines
- Capability to influence, mentor, and drive best practices within matrix environments
Nice to Haves
- Experience with document management systems or regulatory information management tools
- Additional language skills for global coordination
- Background in process improvement or digital transformation in regulatory operations
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Hub Submissions Manager employer: Next Phase Recruitment
Join a dynamic and innovative pharmaceutical manufacturing organisation in Northern Ireland, where your expertise as a Technical Operations Lead will be valued and impactful. We foster a collaborative work culture that prioritises employee growth through continuous learning opportunities and cross-functional teamwork, ensuring you thrive in your career while contributing to meaningful advancements in healthcare. Enjoy the unique advantage of working in a state-of-the-art facility that champions compliance and quality, all while being part of a supportive community dedicated to excellence.
