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- Tasks: Lead regulatory start-up strategies and ensure compliance across projects.
- Company: Join Novotech, a leader in clinical research and biotech.
- Benefits: Flexible working options, wellness programs, and inclusive workplace culture.
- Why this job: Make a real impact in clinical research while growing your career.
- Qualifications: Degree in life sciences and 3+ years in regulatory operations.
- Other info: We value diversity and are committed to gender equality.
The predicted salary is between 36000 - 60000 £ per year.
Join to apply for the Regulatory Start Up Manager role at Novotech.
Responsibilities
- Define a Regulatory Start Up (RSU) strategy and prepare an RSU management plan.
- Oversee the execution of regulatory start up for assigned projects in accordance with agreed RSU strategy.
- Ensure collaboration with local regulatory start up teams to successfully deliver the agreed project scope in compliance with the RSU management plan.
- Distribute start up related documents to local regulatory start up teams.
- Oversee customization of core start-up documents to local requirements.
- Ensure preparation and distribution of core contract and budget templates to applicable team members.
- Oversee submission processes to health authorities, ethics committees and other review bodies.
- Provide regional coordination for meeting approval timelines.
- Oversee site activation package compilation and approvals.
- Proactively identify any risks to start up and escalate to Project Manager.
- Provide timely update of regulatory start up progress to Project Manager.
- Present at external and internal meetings including but not limited to project internal and external meetings, kick-off meetings.
Qualifications
- Graduate in a clinical, pharmacy or life sciences related field.
- Experience managing start up in more than one country and/or region.
- At least 3 years' experience from a CRO or the pharmaceutical industry in activities related to trial start-up and/or regulatory operations.
- Through knowledge of applicable regulations.
- Able to manage in a matrix environment.
- Confident decision-making and problem-solving.
- Strong presentation, documentation, and people skills.
- High proficiency in English.
Benefits and commitments
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working in clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.
Regulatory Start Up Manager in London employer: Novotech
Contact Detail:
Novotech Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Start Up Manager in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research and biotech fields. Attend industry events or webinars, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by researching Novotech and understanding their values and projects. Tailor your responses to show how your experience aligns with their needs, especially in regulatory start-up management. We want to see your passion shine through!
✨Tip Number 3
Practice your presentation skills! As a Regulatory Start Up Manager, you’ll need to present at meetings. Grab a friend or use a mirror to rehearse your delivery. Confidence is key, and we want you to nail it!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re serious about joining our team at Novotech. Let’s get you started on this exciting journey!
We think you need these skills to ace Regulatory Start Up Manager in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Start Up Manager role. Highlight your experience in managing start-ups across different countries and your knowledge of applicable regulations. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about clinical research and how your skills make you a great fit for our team. Don’t forget to mention any relevant experiences that showcase your problem-solving and decision-making abilities.
Showcase Your Soft Skills: In addition to your technical skills, we value strong presentation and people skills. Make sure to include examples of how you've effectively communicated and collaborated with teams in your previous roles. This will help us see how you can contribute to our inclusive work environment.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets to us quickly and efficiently. Plus, you’ll find all the details about the role and our company culture there!
How to prepare for a job interview at Novotech
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations and guidelines relevant to clinical trials and start-up processes. Being able to discuss specific regulations and how they apply to the role will show that you're not just familiar with the basics, but that you’re genuinely knowledgeable.
✨Showcase Your Project Management Skills
Prepare examples of how you've successfully managed start-up projects in the past. Highlight your experience in coordinating with local teams and how you’ve navigated challenges in a matrix environment. This will demonstrate your ability to oversee multiple aspects of regulatory start-up effectively.
✨Be Ready to Discuss Risk Management
Think about potential risks that can arise during the start-up phase and how you would address them. Be prepared to share specific instances where you identified risks and escalated them appropriately. This shows your proactive approach and problem-solving skills.
✨Practice Your Presentation Skills
Since you'll be presenting at various meetings, practice articulating your thoughts clearly and confidently. Consider doing mock presentations with friends or colleagues to get comfortable. This will help you convey your ideas effectively during the interview and beyond.
