At a Glance
- Tasks: Lead regulatory start-up strategies and ensure project compliance across multiple regions.
- Company: Join Novotech, a leader in clinical research and biotech innovation.
- Benefits: Enjoy flexible working options, wellness programs, and inclusive workplace culture.
- Other info: We are committed to gender equality and inclusivity in our hiring process.
- Why this job: Be part of a passionate team making a real impact in healthcare.
- Qualifications: Must have a degree in life sciences and 3+ years in regulatory operations.
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 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.
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Regulatory Start Up Manager employer: Novotech
At Novotech, we pride ourselves on being an employer of choice, offering a dynamic and inclusive work environment that champions flexibility and professional growth. Our commitment to gender equality and support for diverse backgrounds ensures that every team member feels valued and empowered to make a meaningful impact in the clinical research field. With access to mentorship, wellness programs, and a culture that fosters collaboration, Novotech is the ideal place for passionate individuals looking to advance their careers while contributing to life-changing healthcare solutions.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Start Up Manager
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Novotech. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Novotech.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Novotech. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Novotech is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Regulatory Start Up Manager
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Novotech!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Novotech that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Novotech!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Novotech, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Novotech
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Novotech that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Novotech’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
