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- Tasks: Lead the integration of tech and personalized healthcare solutions in a dynamic role.
- Company: Join a forward-thinking organization focused on innovative patient care and outcomes.
- Benefits: Enjoy a collaborative environment with opportunities for professional growth and impactful work.
- Why this job: Be at the forefront of precision medicine, shaping the future of healthcare with cutting-edge strategies.
- Qualifications: Requires a BSc and 7+ years in regulatory experience; advanced degrees preferred.
- Other info: Ideal for those passionate about driving change in complex regulatory landscapes.
The predicted salary is between 43200 - 72000 £ per year.
The Senior Manager Precision Medicine and Digital Health will play a pivotal role in advancing the integration of cutting-edge technologies and personalized healthcare solutions within the organization. This individual will drive initiatives at the intersection of genomics, data science, and digital health, enabling innovative approaches to patient care and outcomes. They will collaborate with cross-functional teams to develop and execute strategies that align with the organization\’s mission and goals.
Responsibilities:
Develop and execute Precision Medicine and Digital Health (PM/DH) regulatory strategies for assigned assets across the therapeutic portfolio, ensuring alignment with global regulatory requirements, internal policies, and delivering optimal labeling based on available data.
- Develop and implement regional and global PM/DH regulatory strategies, ensuring timely delivery in collaboration with cross-functional teams.
- Lead regulatory interactions and processes, including communication with regulatory authorities and external partners.
- Ensure compliance with regulations throughout the product lifecycle.
- Advocate for innovative regulatory approaches to senior leadership and health authorities.
- Assess PM/DH components in potential in-licensing opportunities.
- Challenge and refine processes to improve performance.
- Set and achieve ambitious yet realistic team goals.
- Foster effective matrix collaboration and communication.
- Resolve conflicts and deliver creative, compliant solutions to regulatory challenges.
- Make sound decisions under uncertainty, balancing risks and benefits.
Requirements:
- BSc in a scientific field
- Minimum 7 years\’ of regulatory experience with in vitro diagnostics, companion diagnostics, and SaMD in a major market
- Experience with clinical trial and licensing requirements for PM/DH products
Preferred Qualifications:
- MS or PhD in related fields
- Proven leadership in global development, submissions, and regulatory approvals
- Strong communication, conflict resolution, and change management skills
- Ability to deliver impactful results and lead teams in complex regulatory environments
Senior Manager Precision Medicine, Digital Health employer: SciPro
Contact Detail:
SciPro Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager Precision Medicine, Digital Health
✨Tip Number 1
Familiarize yourself with the latest trends in precision medicine and digital health. Understanding the current landscape will help you speak confidently about how your experience aligns with the role.
✨Tip Number 2
Network with professionals in the field of regulatory affairs, especially those who have experience with in vitro diagnostics and SaMD. Engaging with industry experts can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully navigated regulatory challenges in the past. Highlighting your problem-solving skills and ability to deliver compliant solutions will set you apart.
✨Tip Number 4
Stay updated on global regulatory changes that impact precision medicine and digital health. Demonstrating your proactive approach to compliance will show that you're committed to excellence in this field.
We think you need these skills to ace Senior Manager Precision Medicine, Digital Health
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in precision medicine, digital health, and regulatory affairs. Use specific examples that demonstrate your leadership skills and ability to navigate complex regulatory environments.
Craft a Compelling Cover Letter: In your cover letter, express your passion for advancing personalized healthcare solutions. Discuss how your background aligns with the responsibilities of the role and provide examples of successful initiatives you've led in the past.
Highlight Relevant Experience: When detailing your work history, focus on your regulatory experience with in vitro diagnostics and companion diagnostics. Mention any specific projects or achievements that showcase your ability to develop and execute regulatory strategies.
Showcase Communication Skills: Since strong communication is crucial for this role, include examples of how you've effectively collaborated with cross-functional teams and resolved conflicts in previous positions. This will demonstrate your capability to advocate for innovative regulatory approaches.
How to prepare for a job interview at SciPro
✨Showcase Your Regulatory Expertise
Be prepared to discuss your extensive experience in regulatory affairs, particularly with in vitro diagnostics and companion diagnostics. Highlight specific examples where you successfully navigated complex regulatory environments and achieved approvals.
✨Demonstrate Cross-Functional Collaboration
Since the role involves working with various teams, share instances where you effectively collaborated across departments. Emphasize your ability to foster communication and resolve conflicts to achieve common goals.
✨Highlight Innovative Approaches
Discuss any innovative regulatory strategies you have advocated for in the past. Show how you can think outside the box while ensuring compliance, and be ready to suggest new ideas that could benefit the organization.
✨Prepare for Scenario-Based Questions
Expect questions that assess your decision-making skills under uncertainty. Prepare to discuss how you balance risks and benefits in regulatory decisions, and provide examples of how you've handled challenging situations in the past.
