About the job

Regulatory Consultant – Clinical Trial Strategy & SubmissionsLocation: Maidenhead - 3 days a week on site – Tues, Wed, ThursContract: 12 months

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.

Key ResponsibilitiesManage 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.
Provide regulatory advice on submission strategies, country-specific requirements and regulatory processes.
Act as a Subject Matter Expert (SME) on EU CTR submissions, including complex and platform trials.
Guide cross-functional teams through EU CTR processes and provide training and education where required.
Develop strategies for CTR transitions and initial submissions, working closely with key stakeholders and incorporating lessons learned into processes.
Lead CTA-specific scientific advice procedures, advising study teams and management on available options and appropriate strategies.
Review and provide input into clinical trial submission documents, including Investigator Brochures and protocols.
Ensure regulatory processes and procedures are followed within agreed timelines.
Monitor project milestones against planned activities and proactively identify and communicate issues, risks and changes to relevant stakeholders.
Support inspection readiness activities where required.
Maintain awareness of regulatory intelligence relating to clinical trials and provide relevant advice to stakeholders.
Ensure regulatory databases, trackers and relevant systems are accurately maintained and updated within required timelines.
Provide technical support with regulatory documentation, including Excel spreadsheets and PowerPoint presentations.
Complete all required training to ensure compliance with internal and external processes.
Provide wider operational support to the Clinical Trial Strategy & Submissions team as required.

EducationRequired:Bachelor's degree in Medicine, Pharmacy, Biology, Chemistry, Pharmacology or a related Life Sciences discipline.

Preferred:Advanced degree in a relevant Life Sciences subject.

Essential Experience & Skills5–6+ years of CTA experience, preferably including global clinical trial submissions to regulatory agencies.
Strong understanding of EU Clinical Trials Regulation (EU CTR) processes and requirements.
Experience working effectively across different cultures and within a complex matrix organisation.
Strong IT skills, with experience using MS Word, Excel, PowerPoint, Adobe Acrobat and regulatory databases.
Excellent written and verbal communication skills, with fluency in English.
Strong presentation, interpersonal and stakeholder management skills.
Proactive and solution-focused approach with a high level of initiative.
Ability to work independently while collaborating effectively with cross-functional teams.
Strong organisational and project management skills, with the ability to manage multiple priorities and activities against business and study timelines.
Strong critical reasoning and problem-solving skills, including the ability to identify, resolve and appropriately escalate complex issues.
Ability to establish and maintain effective working relationships with stakeholders across different geographical locations.
Good understanding of business needs and the impact of regulatory issues on clinical development programmes.

Ideal CandidateThe 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.

Responsibilities

About the job

Regulatory Consultant – Clinical Trial Strategy & SubmissionsLocation: Maidenhead - 3 days a week on site – Tues, Wed, ThursContract: 12 months

Key ResponsibilitiesManage 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.
Provide regulatory advice on submission strategies, country-specific requirements and regulatory processes.
Act as a Subject Matter Expert (SME) on EU CTR submissions, including complex and platform trials.
Guide cross-functional teams through EU CTR processes and provide training and education where required.
Develop strategies for CTR transitions and initial submissions, working closely with key stakeholders and incorporating lessons learned into processes.
Lead CTA-specific scientific advice procedures, advising study teams and management on available options and appropriate strategies.
Review and provide input into clinical trial submission documents, including Investigator Brochures and protocols.
Ensure regulatory processes and procedures are followed within agreed timelines.
Monitor project milestones against planned activities and proactively identify and communicate issues, risks and changes to relevant stakeholders.
Support inspection readiness activities where required.
Maintain awareness of regulatory intelligence relating to clinical trials and provide relevant advice to stakeholders.
Ensure regulatory databases, trackers and relevant systems are accurately maintained and updated within required timelines.
Provide technical support with regulatory documentation, including Excel spreadsheets and PowerPoint presentations.
Complete all required training to ensure compliance with internal and external processes.
Provide wider operational support to the Clinical Trial Strategy & Submissions team as required.

EducationRequired:Bachelor's degree in Medicine, Pharmacy, Biology, Chemistry, Pharmacology or a related Life Sciences discipline.

Preferred:Advanced degree in a relevant Life Sciences subject.

Essential Experience & Skills5–6+ years of CTA experience, preferably including global clinical trial submissions to regulatory agencies.
Strong understanding of EU Clinical Trials Regulation (EU CTR) processes and requirements.
Experience working effectively across different cultures and within a complex matrix organisation.
Strong IT skills, with experience using MS Word, Excel, PowerPoint, Adobe Acrobat and regulatory databases.
Excellent written and verbal communication skills, with fluency in English.
Strong presentation, interpersonal and stakeholder management skills.
Proactive and solution-focused approach with a high level of initiative.
Ability to work independently while collaborating effectively with cross-functional teams.
Strong organisational and project management skills, with the ability to manage multiple priorities and activities against business and study timelines.
Strong critical reasoning and problem-solving skills, including the ability to identify, resolve and appropriately escalate complex issues.
Ability to establish and maintain effective working relationships with stakeholders across different geographical locations.
Good understanding of business needs and the impact of regulatory issues on clinical development programmes.

Ideal CandidateThe 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.