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- 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.
- 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.
- Other info: We are committed to gender equality and inclusivity in our hiring process.
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
Contact Detail:
Novotech Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Start Up Manager
✨Tip Number 1
Familiarise yourself with the specific regulatory requirements in the countries or regions you have experience in. This knowledge will not only help you during interviews but also demonstrate your expertise in managing start-up processes across different jurisdictions.
✨Tip Number 2
Network with professionals in the clinical research and biotech fields, especially those who have worked at Novotech or similar companies. Engaging with them can provide valuable insights into the company culture and expectations for the Regulatory Start Up Manager role.
✨Tip Number 3
Prepare to discuss specific examples from your past experiences where you successfully managed regulatory start-up processes. Highlight your problem-solving skills and how you navigated challenges, as this will showcase your ability to handle the responsibilities of the role.
✨Tip Number 4
Stay updated on the latest trends and changes in regulatory affairs within the clinical research industry. Being knowledgeable about current events and future directions can set you apart during discussions and interviews, showing your commitment to the field.
We think you need these skills to ace Regulatory Start Up Manager
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Regulatory Start Up Manager position at Novotech. Understand the key responsibilities and qualifications required, as this will help you tailor your application.
Tailor Your CV: Customise your CV to highlight relevant experience in regulatory start-up management, particularly in a CRO or pharmaceutical setting. Emphasise your skills in project management, decision-making, and problem-solving, as these are crucial for the role.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also demonstrates your passion for clinical research and biotech. Mention specific experiences that align with the responsibilities of the role, such as managing start-ups across different countries.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects attention to detail, which is essential for the Regulatory Start Up Manager position.
How to prepare for a job interview at Novotech
✨Understand the Regulatory Landscape
Familiarise yourself with the specific regulations and guidelines relevant to the role. Being able to discuss these in detail will demonstrate your expertise and show that you are well-prepared for the responsibilities of a Regulatory Start Up Manager.
✨Showcase Your Project Management Skills
Prepare examples from your past experience where you successfully managed start-up projects across different countries or regions. Highlight your ability to coordinate teams and manage timelines effectively, as this is crucial for the role.
✨Emphasise Collaboration and Communication
Since the role involves working closely with local regulatory teams, be ready to discuss how you foster collaboration and ensure clear communication. Share specific instances where your people skills made a difference in project outcomes.
✨Prepare for Scenario-Based Questions
Anticipate questions that may ask how you would handle specific challenges related to regulatory start-up processes. Think through potential risks and your strategies for escalation and resolution, as this will showcase your problem-solving abilities.
