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- Tasks: Lead regulatory activities for cancer clinical trials across multiple countries.
- Company: Join Theradex Oncology, a pioneer in cancer clinical trials with over 40 years of experience.
- Benefits: Enjoy remote work flexibility and the chance to collaborate globally.
- Why this job: Make a real impact in oncology while working in a supportive, innovative environment.
- Qualifications: Bachelor’s in life sciences and 5+ years in regulatory roles required.
- Other info: This role does not offer company sponsorship; equal opportunity employer.
The predicted salary is between 48000 - 72000 £ per year.
Direct message the job poster from Theradex Oncology
I\’m an HR professional with strong organizational & customer support skills. I have the expertise in arranging client meetings, telephone/ F2F…
ABOUT THIS ROLE
Theradex Oncology is celebrating 40+ Years. It is a full-service CRO conducting cancer clinical trials in U.S., Europe and Asia. We are looking for Senior Regulatory Affairs Manager to join our team.
You will work collaboratively with cross-departmental activities on all regulatory activities to drive best practice across the organisation and provide strategic, tactical and operational input to all projects as needed.
The role can be based remotely in the UK, France, Italy, Spain, Sweden or Republic of Ireland.
KEY ACCOUNTABILITIES
- Manage preparation, assembly and submissions of CTAs. Country ICFs in EU/EEA and UK
- Prepares presentations and represent the department at Kick Off Meetings (KOM) with clients.
- Identify country specific requirements and the need for additional country specific applications besides CTIS/IRAS applications e.g., related to radiation safety and biobanks.
- Serves as key regulatory liaison for multi-continental projects on behalf of Theradex Oncology (Europe). Liaison with other departments within Theradex, including but not limited to Clinical Operations, Medical Writing Pharmacovigilance, Quality Assurance and Drug Distribution.
- Be Subject Matter Expert for specific assigned topics e.g., Medical Device, National requirements related to C-ICF in a group of countries
- Review of Regulatory SOPs and other Regulatory Quality Documents.
- Review and provide input from a regulatory perspective on scientific documents (IMPDs, DSURs, study protocols and IBs).
- Validate and provide input into clients’ regulatory development strategies, support clients in preparing for Scientific Advice meetings with EU Competent Authorities and the EMA and prepare applications such as Orphan Drug, Compassionate Use where required.
- Support Head of Regulatory Affairs in business development activities such as preparation of client proposals and bid defense meetings.
- Provide regulatory training as required.
REQUIREMENTS FOR THIS POSITION
- Bachelor’s degree in a life science field or equivalent required.
- Minimum of 5 years of experience in the pharmaceutical industry or CRO in a regulatory role within the area clinical trials
- Direct experience of CTIS and IRAS CTA preparations and submissions is required
- Experience from national applications such as GMO, radiation safety is preferred
- Fluent knowledge of written and verbal English
- Excellent interpersonal skills
- Strong management skills and the proven ability to meet deadlines
- Ability to anticipate problems relating to projects and to develop and implement solutions.
- Highly organized and result-oriented
- Ability to work independently as well as in a team environment
- Proficient knowledge of Microsoft Office packages including but not limited to Word and Excel
This job does not offer company sponsorship
Theradex is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment.
Seniority level
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Seniority level
Mid-Senior level
Employment type
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Employment type
Full-time
Job function
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Job function
Research and Other
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Senior Manager Regulatory Affairs employer: Theradex Oncology
Contact Detail:
Theradex Oncology Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager Regulatory Affairs
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience in clinical trials. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and requirements in regulatory submissions.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks and guidelines relevant to the countries you will be working with, such as CTIS and IRAS. This knowledge will not only enhance your expertise but also demonstrate your commitment to the role during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences in managing regulatory submissions and how you navigated challenges. Be ready to provide examples of how you collaborated with cross-departmental teams to achieve successful outcomes in past projects.
✨Tip Number 4
Showcase your ability to anticipate regulatory challenges by discussing any proactive measures you've taken in previous roles. Highlight your problem-solving skills and how they can benefit Theradex Oncology in managing complex regulatory landscapes.
We think you need these skills to ace Senior Manager Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, particularly in clinical trials. Emphasise your familiarity with CTIS and IRAS submissions, as well as any specific country requirements you've managed.
Craft a Compelling Cover Letter: In your cover letter, express your passion for oncology and regulatory affairs. Mention how your skills align with the key accountabilities of the role, such as managing submissions and liaising with cross-departmental teams.
Showcase Your Expertise: Highlight your subject matter expertise in areas like medical devices or national applications. Provide examples of how you've successfully navigated complex regulatory environments in previous roles.
Proofread and Edit: Before submitting your application, thoroughly proofread your documents. Ensure there are no grammatical errors and that your writing is clear and professional, reflecting your strong communication skills.
How to prepare for a job interview at Theradex Oncology
✨Know Your Regulatory Frameworks
Familiarise yourself with the specific regulatory frameworks relevant to the role, such as CTIS and IRAS. Be prepared to discuss your direct experience with these systems and how you've successfully navigated them in past roles.
✨Demonstrate Cross-Departmental Collaboration
Highlight your experience working collaboratively with various departments like Clinical Operations and Quality Assurance. Prepare examples of how you’ve effectively liaised between teams to drive projects forward.
✨Showcase Your Problem-Solving Skills
Be ready to discuss specific challenges you've faced in regulatory affairs and how you developed solutions. This will demonstrate your ability to anticipate problems and implement effective strategies.
✨Prepare for Client Interaction Scenarios
Since the role involves client meetings and presentations, practice articulating your thoughts clearly and confidently. Consider preparing a mock presentation to showcase your communication skills and regulatory knowledge.