Senior Regulatory Specialist
SRG ·
p strong Regulatory Consultant – Clinical Trial Strategy Submissions /strong /p p strong Location: /strong Maidenhead - 3 days a week on site – Tues, Wed, Thurs /p p strong Contract: /strong 12 months /p p br /p p We are currently seeking an experienced Regulatory Consultant to join a Clinical Trial Strategy Submissions team in Maidenhead.
This is an excellent opportunity for a regulatory professional with strong Clinical Trial Application (CTA) experience and expertise in EU Clinical Trials Regulation (EU CTR) submissions to support global clinical development programmes. /p p br /p p strong Key Responsibilities /strong /p ul li Manage a portfolio of Clinical Trial Applications (CTAs), including preparation and distribution of documentation for initial submissions, substantial amendments, end-of-trial notifications and other maintenance activities. /li li Provide regulatory advice on submission strategies, country-specific requirements and regulatory processes. /li li Act as a Subject Matter Expert (SME) on EU CTR submissions, including complex and platform trials. /li li Guide cross-functional teams through EU CTR processes and provide training and education where required. /li li Develop strategies for CTR transitions and initial submissions, working closely with key stakeholders and incorporating lessons learned into processes. /li li Lead CTA-specific scientific advice procedures, advising study teams and management on available options and appropriate strategies. /li li Review and provide input into clinical trial submission documents, including Investigator Brochures and protocols. /li li Ensure regulatory processes and procedures are followed within agreed timelines. /li li Monitor project milestones against planned activities and proactively identify and communicate issues, risks and changes to relevant stakeholders. /li li Support inspection readiness activities where required. /li li Maintain awareness of regulatory intelligence relating to clinical trials and provide relevant advice to stakeholders. /li li Ensure regulatory databases, trackers and relevant systems are accurately maintained and updated within required timelines. /li li Provide technical support with regulatory documentation, including Excel spreadsheets and PowerPoint presentations. /li li Complete all required training to ensure compliance with internal and external processes. /li li Provide wider operational support to the Clinical Trial Strategy Submissions team as required. /li /ul p br /p p strong Education /strong /p p strong Required: /strong /p ul li Bachelors degree in Medicine, Pharmacy, Biology, Chemistry, Pharmacology or a related Life Sciences discipline. /li /ul p br /p p strong Preferred: /strong /p ul li Advanced degree in a relevant Life Sciences subject. /li /ul p br /p p strong Essential Experience Skills /strong /p ul li 5–6+ years of CTA experience, preferably including global clinical trial submissions to regulatory agencies. /li li Strong understanding of EU Clinical Trials Regulation (EU CTR) processes and requirements. /li li Experience working effectively across different cultures and within a complex matrix organisation. /li li Strong IT skills, with experience using MS Word, Excel, PowerPoint, Adobe Acrobat and regulatory databases. /li li Excellent written and verbal communication skills, with fluency in English. /li li Strong presentation, interpersonal and stakeholder management skills. /li li Proactive and solution-focused approach with a high level of initiative. /li li Ability to work independently while collaborating effectively with cross-functional teams. /li li Strong organisational and project management skills, with the ability to manage multiple priorities and activities against business and study timelines. /li li Strong critical reasoning and problem-solving skills, including the ability to identify, resolve and appropriately escalate complex issues. /li li Ability to establish and maintain effective working relationships with stakeholders across different geographical locations. /li li Good understanding of business needs and the impact of regulatory issues on clinical development programmes. /li /ul p br /p p strong Ideal Candidate /strong /p p The ideal candidate will be an experienced Clinical Trial Regulatory professional with strong hands-on CTA submission experience and a detailed understanding of EU CTR requirements.
You will be confident working with cross-functional and international teams, managing multiple regulatory activities and providing strategic regulatory advice throughout the clinical trial lifecycle. /p