At a Glance
- Tasks: Lead and manage regulatory submissions for clinical trials across Europe.
- Company: Join ICON, a leader in innovative Pharma projects focused on life-improving drugs.
- Benefits: Enjoy flexible working options and a culture that values innovation and collaboration.
- Other info: Home-based role with opportunities for professional growth and development.
- Why this job: Be part of a dynamic team making a real impact in the healthcare industry.
- Qualifications: Degree in Pharmacy, Life Sciences, or related field; experience with EU CTR is essential.
The predicted salary is between 42000 - 84000 £ per year.
An exciting new role with ICON within our regulatory team working on high profile Pharma projects with a client with which ICON shares a culture of innovation, flexibility and a common vision of bringing life-improving drugs to market.
The Regional CTA Submission Manager (CTA-SM) is accountable for working with contributing to business lines to lead operational submissions execution for designated CTAs. They may operate as regulatory operational Subject Matter Expert for EU CTR and drive submission teams towards the timely delivery of globally compliant submission-ready components.
Role Responsibilities- Drives regional submission management strategy and activities for assigned protocols.
- Partners with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development including authoring of Annex I and completion of relative associated documentation as required.
- Lead and attends relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities.
- Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
- Liaises with Core team, SSU and Study Management, regarding essential core documents and local documentation as needed from relevant supplier lines across both HA and EC submission and translation processes.
- Prepare, review and support submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
- Responsible for the co-ordination of translations for core documents required for submission.
- Manages the compilation for core package build, contributing to CTA and authoring documentation as required.
- CTA Manager may act as local country liaison when required.
- Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.
- S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
- In-depth understanding and proven execution of CTA and Central Ethics processes regionally.
- Must have experience in EU CTR.
- Hands on submission experience using CTIS.
- Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards.
Regulatory CTA submission Manager in Coventry employer: CTI Clinical Trial and Consulting Services
At ICON, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters innovation and flexibility. Our home-based roles in the UK and Europe provide employees with the opportunity to work on high-profile Pharma projects while enjoying a supportive environment that prioritises professional growth and development. With a commitment to bringing life-improving drugs to market, we empower our team members to make a meaningful impact in the healthcare industry.
Contact Details:
CTI Clinical Trial and Consulting Services Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory CTA submission Manager in Coventry
✨Tip Number 1
Familiarise yourself with the EU Clinical Trials Regulation (EU CTR) and its implications for submission processes. Understanding the nuances of this regulation will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with CTA submissions. Engaging in discussions or attending relevant webinars can provide insights and potentially lead to referrals.
✨Tip Number 3
Stay updated on the latest trends and changes in regulatory guidelines by following industry news and publications. This knowledge can be a great conversation starter during interviews and shows your proactive approach.
✨Tip Number 4
Prepare to discuss specific examples from your past experiences that highlight your ability to manage submissions and collaborate with cross-functional teams. Tailoring your stories to align with the responsibilities outlined in the job description can make a strong impression.
We think you need these skills to ace Regulatory CTA submission Manager in Coventry
Some tips for your application 🫡
Understand the Role:Before applying, make sure you fully understand the responsibilities of a Regulatory CTA Submission Manager. Familiarise yourself with the EU CTR and the specific requirements mentioned in the job description.
Tailor Your CV:Highlight your relevant experience in regulatory submissions, particularly in the context of EU CTR. Use specific examples that demonstrate your understanding of the processes and your ability to manage submissions effectively.
Craft a Compelling Cover Letter:Write a cover letter that not only outlines your qualifications but also expresses your passion for the role and the pharmaceutical industry. Mention how your values align with ICON's culture of innovation and flexibility.
Proofread Your Application:Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial for a role that involves compliance and regulatory standards.
How to prepare for a job interview at CTI Clinical Trial and Consulting Services
✨Understand the Regulatory Landscape
Familiarise yourself with the EU Clinical Trials Regulation (EU CTR) and its implications for CTA submissions. Being able to discuss recent changes or updates in regulations will demonstrate your expertise and commitment to the role.
✨Showcase Your Submission Experience
Prepare specific examples of your hands-on experience with submission processes, particularly using CTIS. Highlight any successful projects where you managed timelines and ensured compliance with regulatory standards.
✨Emphasise Team Collaboration
Since the role involves working closely with study teams and various stakeholders, be ready to discuss how you have effectively collaborated in past roles. Share examples of how you advocated for realistic timelines and managed expectations.
✨Prepare for Scenario-Based Questions
Anticipate questions that may ask how you would handle specific challenges related to submission builds or logistics. Think through potential scenarios and articulate your problem-solving approach clearly.
