!
*Regulatory Start up Specialist - Remote in the UK - Global Life science*!
Location: Remote in the UK FTE: Full time Start date: ASAP Planet Pharma are working with a global organization that specializes in supporting life sciences companies in developing and commercializing innovative therapies, particularly in precision medicine.
They provide tailored services across the entire drug development lifecycle, with a focus on integrating scientific expertise, advanced analytics, and operational support.
Job Summary : We are seeking a highly skilled and motivated (Senior) Regulatory and Start-Up Specialist to join our team.
This role is pivotal in ensuring seamless regulatory compliance and site activation readiness, with a focus on quality, timeliness, and collaboration across functional teams.. ROLE RESPONSIBILITIES Regulatory Submissions and Approvals: Prepare Clinical Trial Application Forms and submission dossiers (initial, amendments, and notifications) for Competent Authorities (CA), Ethics Committees (EC), and other local bodies.
Ensure submissions meet local, national, and international regulations, company SOPs, and ICH-GCP principles within specified timelines.
Liaise with CA/EC for study-related submissions, respond to inquiries, and manage communication effectively.
Project and Stakeholder Management: Provide regular updates to the Regulatory Lead, Project Manager, and Project Team on submission status and milestones.
Maintain project plans, trackers, and regulatory intelligence tools to support efficient operations.
Partner with CRAs and other key stakeholders to ensure alignment and secure site collaboration.
Start-Up and Site Activation: Oversee site activation readiness within assigned countries/sites, mitigating risks and ensuring delivery of high-quality outcomes.
Develop and support study-specific start-up plans, including IMP release requirements and essential document review criteria.
Review and manage the collection of essential documents required for site activation/IMP release.
Customize Patient Information Sheets and Informed Consent Forms to meet country/site-specific requirements.
Collaboration and Coordination: Coordinate translations of documents required for submissions, ensuring accuracy and regulatory compliance.
Collaborate with Feasibility, Clinical Operations, Project Management, and Site Contracts teams to ensure seamless communication and delivery.
Act as a Subject Matter Expert (SME) on site activation processes, timelines, and data points, such as CA/EC reviews, site contracts, and budget negotiations.
Requirements: Be proficient in preparing regulatory submissions in the UK (combined review through IRAS, Radiation assurance, ARSAC).
Must have proven recent experience on this, and be able to work independently on this (ie: completing medicines form, radiation form, providing advice on required documents for regulatory submissions, etc).
Be proficient in creating budget using Interactive Costing Tool (iCT) in CPMS.
Be proficient in performing country adaptation for the UK for ICF's.
If you would like to discuss this vacancy further or to discuss your career options in confidence, please email me on: ****** If this role isn't suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated!
Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!
About Planet Pharma Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London.
We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field.
Just recently we were recognized by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery.
We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency.
We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age