WHO WE ARE
IDEA Regulatory are a regulatory affairs consultancy for the pharmaceutical, biotechnology and medical device industries. We work with small and medium sized, innovative medicines and device developers helping guide them through the European regulatory process for their clinical trial approvals and market authorisations. We also work with global partners to bring European expertise to global projects. We serve clinical trial sponsors and MAH's by providing regulatory affairs strategies and services, and for our non-EU or UK based clients we provide specialist EU and UK representation services.
This is an exciting time to be joining the IDEA Regulatory, as we continue to grow our team in Ireland.
Our Managing Director has grown IDEA from a start-up and she believes in leading with a people first approach. At IDEA Regulatory you will never be micro-managed, we believe in hiring talented people and giving them the support and the space to do their jobs in their own way and supporting them to grow their career on their own path. Self-sufficiency and the ability to communicate workloads, challenges, and project progress is a must to thrive in our team.
WHAT WE ARE OFFERING
The position of Regulatory Affairs Submission Specialist, based in our Maynooth office in Dublin, offers great flexibility and career development opportunities to the right candidate and we are looking for a diligent and enthusiastic personality to join our team.
The Regulatory Affairs Submission Specialist will take an important role in the Company's regulatory activities, managing and overseeing regulatory submissions, providing expert regulatory advice, and ensuring compliance with all relevant regulations. This is a key client-facing role which includes managing and executing complex regulatory submission projects, acting as a key point of contact for regulatory matters, and mentoring junior team members while supporting clients and senior team members.
IDEA Regulatory offers a competitive, experience based, salary, on-the-job and accredited training, with personalised, flexible benefits and company bonus scheme, flexible working, and is a progressive, equal opportunities employer.
YOUR ROLE
The Regulatory Affairs Submission Specialist position is well suited to someone with 2-4 years' experience handling CTIS, SPOR and other regulatory submissions in similar roles in the industry. The postholder will participate and assist in the full scope of submission related activities from educating clients on the requirements, building compliant dossiers, to managing the submission process and regulator communications, and helping keep our internal SOPs up to date.
The specialist will work within a collaborative consultancy team, benefiting from direct input and support from senior regulatory experts and junior consultants, both in house and from our network of subject matter experts and consulting partners.
While responsible for driving submission outcomes and managing client relationships, this is a supported role and no one is expected to solve every issue alone. Team input, training, and cross-functional collaboration are integral to success.
CORE RESPONSIBILITIES OF THE REGULATORY AFFAIRS SUBMISSION SPECIALIST:
* Manage, coordinate, and execute regulatory submissions: (e.g., CTA, IND, MAA, PIP, Scientific Advice) from planning through to completion, ensuring accuracy, timeliness, and compliance with regulatory requirements. Submit dossiers and follow-up responses via the relevant portal (SPOR, IRAS, CTIS, etc.)
* Coordinate document development activities: Act as the primary liaison with clients for submission projects, maintaining proactive communication to understand objectives, oversee timelines, provide updates, and address queries.
* Offer expert advice to clients: on developing submission documents, submission plans, interpreting guidelines, submission strategy, and ensuring alignment with client development timelines.
* Support dossier development activities: Collaborate with the client and regulatory team to assign, oversee, and support submission efforts, drawing on expertise from both senior and junior colleagues to balance workload and ensure quality delivery. Assist with document drafting and reviewing document drafts for regulatory compliance and submission readiness, and formatting, etc.
* Lead meetings (internal and client-facing): to discuss submission strategy, review documents, identify and address challenges, and finalise deliverables.
* Manage regulator correspondence: throughout the submission procedure, including tracking and resolving regulatory agency queries, preparing responses (with client and team inputs), and handling interaction with authorities to facilitate approvals and troubleshooting.
Strategic Impact:
* Beyond operational duties, the role involves strategic thinking, issue resolution, and acting as a trusted advisor to clients for both routine and complex submissions.
* Opportunities exist to shape internal processes, improve submission strategies, and directly influence the client experience.
YOUR REQUIRED SKILLS & QUALIFICATIONS
* 2-4 years' experience in Regulatory Affairs submissions based activities.
* Bachelor's or higher degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, or a related scientific discipline.
* Demonstrated expertise in preparing and managing regulatory submissions (e.g., CTA/IND, MAA, Scientific Advice, Orphan Drug Designations)
* Proficiency with electronic submission tools and portals such as eCTD publishing software and the EMA CTIS and SPOR portals, and proficient in Microsoft office suite applications
* Experience liaising with regulatory authorities (EMA, MHRA, FDA etc.) and handling agency queries.
* Strong understanding of global and regional regulatory requirements and submission processes, including knowledge of relevant guidelines (e.g., ICH, EMA, UK MHRA).
* Ability to work under minimal supervision, detail-oriented with excellent administrative and project planning skills, managing timelines, resource coordination, and multi-stakeholder communication. Experience with MS Project Management or other PM software a bonus.
* Excellent written and verbal communication skills for client liaison, report writing, and documentation review, with the ability to convey complex information clearly.
* Dynamic, curious, adaptable, and driven by a growth mindset.
* Fluent in English language and grammar skills.
The Small Print
No agents please.
Applicants must hold EEA, Swiss or UK citizenship or be in possession of a current, fully approved, permit to work in Ireland plus have full visa approval to travel the UK.
Please submit your CV and complete the application questions.
If you decide to apply for the position, any personal data which you provide shall be processed by IDEA Regulatory and its subsidiary companies. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
Job Type: Full-time
Pay: €35,000.00-€65,000.00 per year
Benefits:
* Company pension
* Flexitime
* On-site parking
* Private medical insurance
* Profit sharing
* Sick pay
* Work from home
Ability to commute/relocate:
* Maynooth, Co. Kildare, CO. Kildare: reliably commute or plan to relocate before starting work (preferred)
Education:
* Bachelor's (required)
Experience:
* Regulatory Affairs: 2 years (required)
* Regulatory Submissons: 2 years (required)
Work authorisation:
* Ireland (required)
Work Location: Hybrid remote in Maynooth, Co. Kildare, CO. Kildare