At a Glance
- Tasks: Lead regulatory start-up strategies and ensure compliance across projects.
- Company: Join Novotech, a leader in clinical research with a commitment to inclusivity.
- Benefits: Enjoy flexible working options, wellness programs, and paid parental leave.
- Other info: We celebrate diversity and are committed to responding to every application.
- Why this job: Make a real impact in biotech while growing your career in a supportive environment.
- Qualifications: Degree in life sciences and 3+ years in regulatory operations required.
The predicted salary is between 36000 - 60000 £ per year.
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 England employer: Novotech
At Novotech, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. As a Senior Director in the UK, you will benefit from our commitment to employee growth through continuous training and development opportunities, while also enjoying a supportive environment that values your contributions to strategic leadership in site engagement and feasibility. Join us to be part of a dynamic team dedicated to delivering high-quality study outcomes and making a meaningful impact in the clinical research landscape.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Start Up Manager in England
✨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 RSU strategy. Be ready to discuss how your experience aligns with their needs. Practise common interview questions and think of examples that showcase your problem-solving skills.
✨Tip Number 3
Follow up after interviews! A quick thank-you email can go a long way in showing your enthusiasm for the role. It’s also a chance to reiterate why you’re the perfect fit for the Regulatory Start Up Manager position.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re genuinely interested in joining the Novotech team. Let’s get you that dream job!
We think you need these skills to ace Regulatory Start Up Manager in England
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in regulatory start-up management. We want to see how your skills align with the responsibilities outlined in the job description.
Showcase Your Experience:Don’t just list your previous roles; explain how your experience managing start-ups across different countries has prepared you for this position. We love seeing concrete examples of your problem-solving and decision-making skills!
Be Clear and Concise:Keep your application straightforward and to the point. Use clear language to describe your qualifications and experiences, as we appreciate clarity and professionalism in written communication.
Apply Through Our Website:We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at Novotech
✨Know Your RSU Strategy
Before the interview, make sure you understand what a Regulatory Start Up (RSU) strategy entails. Familiarise yourself with how to define and execute an RSU management plan, as this will likely be a key focus during your discussion.
✨Showcase Your Experience
Be ready to discuss your experience managing start-ups across different countries or regions. Prepare specific examples that highlight your knowledge of applicable regulations and how you've successfully navigated challenges in a matrix environment.
✨Prepare for Collaboration Questions
Since collaboration is crucial for this role, think about times when you've worked with local regulatory teams. Be prepared to share how you ensured compliance and delivered project scope effectively, as well as how you handled any conflicts that arose.
✨Practice Your Presentation Skills
Given the importance of strong presentation skills in this role, practice presenting your ideas clearly and confidently. You might be asked to present at internal or external meetings, so being articulate and engaging will set you apart from other candidates.
