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- Tasks: Lead projects with health authorities and develop regulatory strategies for digital health.
- Company: DEEP Measures is a fast-growing start-up focused on regulatory science in healthcare.
- Benefits: Enjoy a competitive salary, remote work options, and opportunities for personal growth.
- Why this job: Join a dynamic team and make an impact in the evolving field of digital health.
- Qualifications: Bachelor's or Master's in life sciences; experience in regulatory science and digital health required.
- Other info: We value diversity and inclusivity; all qualified applicants are encouraged to apply.
The predicted salary is between 36000 - 60000 £ per year.
Join to apply for the Regulatory Scientist role at DEEP Measures
Join to apply for the Regulatory Scientist role at DEEP Measures
At DEEP Measures, excellence in regulatory science and thinking has been a key component of our success. In this role, you will collaborate with internal and external stakeholders, including regulators and thought leaders, to lead projects with Health Authorities. You will coordinate the Global Advocacy Network forum with policy experts from our customers and provide advice on regulatory strategy and interactions, focusing on digital measures of health and measurement technologies. This role is ideal for a seasoned regulatory expert interested in advancing this exciting field. Given the rapid developments in this area, curiosity about regulatory science and digital endpoints is essential. You will work with the DEEP model for structured evidence, supporting the creation of measurement definitions, target solution profiles, and digital measurement solutions from a regulatory perspective. You will also lead regulatory pilots with various agencies on both the pharmaceutical and medical device sides
Key Duties and Responsibilities
The followingduties and responsibilities are crucial for a Regulatory Scientist specializing in digital endpoints to ensure successful regulatory approval and compliance:
- Conduct research and stay updated on regulatory requirements related to digital endpoints in the pharmaceutical and healthcare industries.
- In partnership with customers, develop regulatory strategies for digital endpoints, ensuring compliance with relevant guidelines and standards.
- Prepare and submit regulatory submissions to health authorities for digital endpoints qualifications and acceptance, such as Qualification of Novel Methodologies, Scientific Advice, Innovation Task Force in Europe, and IND interactions, DDT qualification procedures in the US.
- Collaborate with cross-functional teams to ensure regulatory requirements are met throughout the product development lifecycle.
- Provide regulatory guidance and support to customers and internal teams on digital endpoint-related matters.
- Participate in meetings with regulatory agencies to discuss digital endpoint submissions and address any questions or concerns.
- Lead projects with regulatory agencies (e.g. pilots)
- Coordinate Global Advocacy Network forum with thought leaders from industry and coordinate project delivery
- Review and assess data generated from digital endpoints to ensure quality, integrity, and compliance with regulatory requirements.
- Contribute to the development of regulatory policies and procedures specific to digital endpoints and partner with industry and regulators to move the ecosystem forward.
- Monitor and track changes in regulations and guidelines related to digital endpoints, and communicate updates to relevant stakeholders.
In addition youwill be responsible for:
- Ensuring appropriate classification of the information in the DEEP Catalog based on confidentiality and copyright, and assigning appropriate level of access.
- Creating, maintaining and adhering to guidelines and standards for populating content in the DEEP Catalog.
- Managing multiple projects simultaneously, coordinating timelines, priorities, and resources to ensure timely completion of deliverables.
- Communicating directly with clients and external stakeholders to understand project requirements, provide updates, and address feedback or questions.
- Other responsibilities as assigned.
Qualifications
- Bachelor or Master’s degree in life sciences, pharmacy, digital health, medical technology or related field.
Required Experience
- Advanced knowledge of the science of digital health and medical technology
- Advanced knowledge of the regulatory science of digital endpoints, including regulatory procedures and strategies
- Knowledge in leading regulatory procedures and working with regulators
- A self-starter that can also collaborate well with a remote team
- A high degree of curiosity and eagerness for learning something new every day
- An ability to work and adapt in a fast-moving start-up environment
- An ability to analyze and synthesize complex information
- Excellent writing and communication skills, including presentation skills
- Experience in regulatory policy and working with external key thought leaders
- Research experience in life sciences
What we offer
We are a young and growing start-up and our team moves at a fast pace. You will have opportunities to work with all the company members and partners, learn different aspects of a business and grow in new areas. We offer a competitive compensation package.
DEEP Measures is an equal opportunity employer
We are committed to fostering a diverse and inclusive workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or disability status.
If you are interested in working with us, please submit your resume and cover letter via our website form.
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Regulatory Scientist employer: DEEP Measures
Contact Detail:
DEEP Measures Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Scientist
✨Tip Number 1
Familiarise yourself with the latest regulatory guidelines and standards related to digital endpoints. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the regulatory science community, especially those focused on digital health. Engaging with thought leaders can provide insights into current trends and may even lead to referrals or recommendations for the role.
✨Tip Number 3
Prepare to discuss specific projects where you've successfully navigated regulatory processes. Highlighting your experience with health authorities and your ability to lead projects will set you apart from other candidates.
✨Tip Number 4
Showcase your curiosity and eagerness to learn by asking insightful questions during interviews. This will reflect your passion for regulatory science and your proactive approach to professional development.
We think you need these skills to ace Regulatory Scientist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory science, particularly with digital endpoints. Use specific examples that demonstrate your knowledge of regulatory procedures and your ability to work with health authorities.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Discuss your curiosity about regulatory science and how your background aligns with DEEP Measures' mission. Be sure to mention any specific projects or experiences that relate to digital health.
Showcase Your Research Skills: Since the role requires staying updated on regulatory requirements, include examples of how you've conducted research in the past. Mention any relevant publications or presentations that demonstrate your expertise in the field.
Highlight Collaboration Experience: Given the collaborative nature of the role, emphasise your experience working with cross-functional teams. Provide examples of successful projects where you coordinated with various stakeholders, especially in a remote setting.
How to prepare for a job interview at DEEP Measures
✨Show Your Curiosity
As a Regulatory Scientist, curiosity about regulatory science and digital endpoints is essential. Be prepared to discuss recent developments in the field and how they might impact your work. This will demonstrate your passion and commitment to staying updated.
✨Highlight Collaborative Experience
This role involves working with various stakeholders, including regulators and thought leaders. Share specific examples of past collaborations, focusing on how you effectively communicated and coordinated with different teams to achieve regulatory goals.
✨Prepare for Technical Questions
Expect questions related to regulatory procedures and strategies for digital endpoints. Brush up on relevant guidelines and be ready to discuss how you would approach regulatory submissions and compliance issues in your previous roles.
✨Demonstrate Project Management Skills
You'll need to manage multiple projects simultaneously. Prepare to discuss your experience in coordinating timelines, priorities, and resources. Use examples that showcase your ability to deliver results under pressure while maintaining quality and compliance.