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- Tasks: Lead regulatory strategy for clinical trials and ensure compliance with regulations.
- Company: Join Precision for Medicine, a leading CRO dedicated to advancing healthcare.
- Benefits: Enjoy remote work flexibility and opportunities for professional growth.
- Why this job: Make a real impact in drug development while working in a dynamic team environment.
- Qualifications: 5-7 years of regulatory experience in clinical research is essential.
- Other info: Candidates from the UK, Spain, Hungary, Slovakia, Serbia, Romania, or Poland are welcome to apply.
The predicted salary is between 36000 - 60000 £ per year.
Precision for Medicine (CRO) is recruiting a Regulatory Manager to join our team. Candidates can be based in the following countries: UK, Spain, Hungary, Slovakia, Serbia, Romania, or Poland.
The Regulatory Manager (RM) provides regulatory strategy and guidance for clinical trials, agency meetings, orphan designations, pediatric planning, and accelerated procedures. The RM ensures timely, well-organized, and compliant regulatory submissions. Responsibilities include preparing documents for submission to authorities and ethics committees, maintaining current knowledge of regulations, and supporting the regulatory function of the organization.
Essential functions include:
- Providing regulatory guidance throughout clinical development
- Compiling and reviewing applications such as CTA/IND, annual reports, amendments, and marketing applications
- Developing and reviewing submission documents for compliance
- Representing Global Regulatory Affairs in project meetings
- Leading or participating in project teams
- Overseeing Regulatory Affairs Specialists to meet submission targets
- Maintaining project plans and regulatory intelligence tools
- Supporting development of Regulatory Affairs staff
- Contributing to regulatory strategy and timelines for new studies
- Participating in corporate quality initiatives
- Staying updated on laws, regulations, and guidelines
- Providing ICH GCP guidance and training
- Representing Regulatory Affairs in business development meetings
Qualifications:
- Bachelor’s degree or equivalent, preferably in a scientific or healthcare field
- At least 5 years of regulatory experience for Manager level, 7 years for Senior Manager
Preferred:
- Basic understanding of financial management
Other requirements:
- Experience working in a Clinical Research Organisation and leading clinical submissions
- Knowledge of drug development, regulatory milestones, and activities in major regions (EU, US)
- Ability to interpret clinical and pre-clinical data for regulatory strategy
- Understanding of clinical trial methodology
- Willingness to travel domestically and internationally
- Strong interpersonal and teamwork skills
- Professionalism, punctuality, and commitment
- Ability to manage multiple tasks efficiently
- Self-motivated and proactive in work planning
- Effective communication skills in English, both verbal and written
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Regulatory Manager / Senior Regulatory Manager employer: Precision Medicine Group
Contact Detail:
Precision Medicine Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Manager / Senior Regulatory Manager
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience in clinical research organisations. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends in regulatory strategies.
✨Tip Number 2
Stay updated on the latest regulations and guidelines governing drug development, particularly in the EU and US. This knowledge will not only enhance your expertise but also demonstrate your commitment to the role during interviews.
✨Tip Number 3
Prepare to discuss specific examples of your past regulatory submissions and how you navigated challenges. Highlight your ability to lead projects and collaborate with cross-functional teams, as these skills are crucial for the Regulatory Manager position.
✨Tip Number 4
Familiarise yourself with Precision for Medicine's corporate values and recent projects. Tailoring your conversation to align with their mission can set you apart and show that you're genuinely interested in contributing to their success.
We think you need these skills to ace Regulatory Manager / Senior Regulatory Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant regulatory experience, especially in clinical research organisations. Emphasise your understanding of drug development processes and any specific regulatory submissions you've managed.
Craft a Compelling Cover Letter: In your cover letter, clearly articulate why you're interested in the Regulatory Manager position at Precision for Medicine. Mention your experience with regulatory strategy and how it aligns with their needs, showcasing your ability to lead and support project teams.
Highlight Key Qualifications: Ensure you address the essential qualifications listed in the job description. Discuss your years of regulatory experience, your educational background, and any specific knowledge of EU or US regulations that would be beneficial for the role.
Showcase Soft Skills: Regulatory roles require strong interpersonal skills. In your application, provide examples of how you've successfully collaborated with teams, managed multiple tasks, and communicated effectively in high-pressure environments.
How to prepare for a job interview at Precision Medicine Group
✨Know Your Regulations
Make sure you have a solid understanding of the regulations and guidelines governing drug development, especially in the EU and US. Be prepared to discuss specific regulatory submissions you've worked on and how they align with current standards.
✨Showcase Your Experience
Highlight your experience in leading clinical submissions and working within a Clinical Research Organisation. Be ready to provide examples of how you've successfully navigated complex regulatory challenges in past roles.
✨Demonstrate Team Collaboration
Since the role involves working closely with project teams, be prepared to discuss how you've collaborated with others in previous positions. Share examples of how you motivated team members and contributed to achieving project goals.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills and ability to manage multiple tasks. Think of situations where you've had to prioritise workload or resolve project-related issues, and be ready to explain your thought process.
