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Precision Medicine GroupRegulatory and Start Up Specialist
Precision Medicine Group is seeking a Regulatory and Start Up Specialist to join its team. Based in the United Kingdom, this remote, full-time position involves supporting…
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About This Role
Precision Medicine Group is seeking a Regulatory and Start Up Specialist to join its team. Based in the United Kingdom, this remote, full-time position involves supporting clinical trials by managing site activation readiness, regulatory submissions, and related documentation. The employer is a global clinical research organization that merges scientific expertise, novel trial designs, advanced biomarker and data analytics, and a focus on oncology and rare diseases. The person in this…
Job Description
Precision Medicine Group is seeking a Regulatory and Start Up Specialist to join its team. Based in the United Kingdom, this remote, full-time position involves supporting clinical trials by managing site activation readiness, regulatory submissions, and related documentation. The employer is a global clinical research organization that merges scientific expertise, novel trial designs, advanced biomarker and data analytics, and a focus on oncology and rare diseases.
The person in this role will prepare clinical trial application forms and submission dossiers for competent authorities, ethics committees, and local bodies. Responsibilities also include handling agency responses, maintaining project plans and trackers, reviewing essential documents, customizing patient information sheets and consent forms, and collaborating with cross-functional teams. Additionally, the specialist may help negotiate study budgets and investigator contracts under the guidance of the site contract management department.
This role suits professionals with a background in clinical research operations, regulatory submissions, and site start-up tasks. Candidates must have relevant industry experience and strong organizational skills.
Responsibilities
- Deliver site activation readiness for assigned countries and sites while mitigating potential risks
- Prepare clinical trial application forms and initial or amendment submission dossiers for competent authorities and ethics committees
- Interact with competent authorities and ethics committees and handle their responses
- Provide regular submission updates to the start-up lead, regulatory lead, and project manager
- Maintain project trackers, plans, and regulatory intelligence tools
- Support the creation of study start-up plans, investigational medicinal product release requirements, and essential document review criteria
- Partner with site clinical research associates to ensure aligned communication and secure site activation
- Review and manage the collection of essential documents required for site activation and investigational product release
- Customize country and site-specific patient information sheets and informed consent forms
- Coordinate document translations and maintain communication with feasibility, clinical operations, project management, regulatory, and contract management groups
- Act as a subject matter expert for site-level critical path data points, including ethics committee timelines and budget requirements
- Negotiate study budgets and execute investigator contracts under the direction of the site contract management department
- Keep updated on local clinical trial laws and regulations and share this knowledge internally
- Maintain audit and inspection readiness while filing documents according to trial master file plans
- Support clinical teams during pre-study site visits when required
Requirements
- At least two years of relevant experience
- Previous experience working as a regulatory and start-up specialist or site contracts specialist in a CRO, pharmaceutical, or biotechnology environment
- Strong communication and organizational skills
- Proficiency in computerized information systems, electronic spreadsheets, word processing, and electronic mail
- Fluency in English
- Legal authorization to work in the employment country without employer sponsorship
Qualifications
- Bachelor degree in life sciences, a scientific or healthcare discipline, or registration as a nurse
- Pharmacy qualification or work experience as a pharmacist
- Experience in site contract and budget negotiations
- Experience using milestone tracking systems
- Advanced degree in medical or life sciences such as an MD, PhD, or PharmD
- Regulatory Affairs Certification
- Master degree in regulatory science
Core Skills
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Where is this job located?
The position is remote and based in the United Kingdom.
What is the employment type?
This is a full-time position.
What experience is required for this role?
Candidates must have at least two years of relevant experience working as a regulatory and start-up specialist or site contracts specialist within a CRO, pharmaceutical, or biotechnology setting.
What is the salary for this position?
The source posting does not specify a salary.
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