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- Tasks: Lead site activation and regulatory submissions for clinical trials across the UK.
- Company: Join Precision for Medicine, a cutting-edge CRO transforming therapy delivery with tech and expertise.
- Benefits: Enjoy fully remote work, flexible hours, and opportunities for professional growth.
- Why this job: Be part of a mission-driven team making a real impact on patient lives through innovative therapies.
- Qualifications: Bachelor’s in life sciences; 3.5+ years in regulatory/start-up roles preferred.
- Other info: Opportunity to mentor junior staff and engage with diverse teams.
The predicted salary is between 36000 - 60000 £ per year.
Precision for Medicine is not your typical CRO. We leverage new technologies, expertise, and operational scale to improve the speed, cost, and success rate of bringing life-changing therapies to patients. Our unique approach integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences.
As our organization grows, we are hiring a Senior Regulatory and Start Up Specialist to join our UK team. This position can be offered fully remote.
Responsibilities include but are not limited to:
- Ensuring timely and quality delivery of site activation within designated countries/sites, anticipating and mitigating risks.
- Preparing Clinical Trial Application Forms and submission dossiers (initial and amendments) for regulatory authorities, ethics committees, and other bodies, adhering to local and international regulations, SOPs, and ICH-GCP principles.
- Interacting with regulatory authorities and ethics committees, managing responses.
- Providing updates on submissions to relevant project leads and teams.
- Maintaining project plans, trackers, and regulatory intelligence tools.
- Supporting the development of start-up plans, IMP release requirements, and document review criteria.
- Collaborating with site CRAs to ensure effective communication and site collaboration.
- Managing collection of essential documents for site activation and IMP release.
- Customizing patient information and consent forms for specific countries/sites.
- Coordinating translations of submission documents.
- Communicating with key functions involved in country start-up processes.
- Acting as SME for critical path data points to ensure on-time site activation.
- Supporting budget negotiations and investigator contract execution as needed.
- Staying updated on local clinical trial laws and regulations, sharing knowledge within PfM.
- Maintaining audit and inspection readiness, filing documents per TMF plan.
- Supporting pre-study site visits and feasibility assessments.
- Developing country-specific start-up summaries and process flows.
- Training staff and mentoring on local start-up regulations and procedures.
- Interacting with clients for status updates and document reviews.
- Performing other duties as assigned.
Qualifications:
- Bachelor’s degree in life sciences or related field; RN or equivalent preferred.
- At least 3.5 years of experience as a Regulatory or Start-Up specialist in CRO or pharma/biotech industry.
Other Requirements:
- Excellent communication and organizational skills.
- Proficiency with computerized systems, spreadsheets, and email.
- Fluent in English.
- Ability to prioritize and meet deadlines.
Preferred Qualifications:
- Experience with UK regulatory and site start-up processes.
- Knowledge of milestone tracking tools.
- Experience mentoring junior staff.
- Advanced degrees or certifications (MD, PhD, PharmD, RAC, etc.).
- Knowledge of GCP/ICH guidelines and local regulations.
- Strong attention to detail, effective communication skills, and ability to work independently in a fast-paced environment.
- Willingness to travel occasionally.
Senior Regulatory and Start Up Specialist employer: JR United Kingdom
Contact Detail:
JR United Kingdom Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory and Start Up Specialist
✨Tip Number 1
Familiarise yourself with the latest UK regulatory guidelines and site start-up processes. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in this fast-paced field.
✨Tip Number 2
Network with professionals in the CRO and pharma/biotech industries. Attend relevant webinars or local meetups to connect with others in the field, which can lead to valuable insights and potential referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've managed site activation and regulatory submissions in your previous roles. Highlighting your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Showcase your mentoring experience if you have it. As the role involves training staff on local regulations, demonstrating your ability to guide and support junior colleagues can be a significant advantage.
We think you need these skills to ace Senior Regulatory and Start Up Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs and start-up processes. Emphasise your familiarity with UK regulations and any specific achievements that demonstrate your expertise in the field.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and the company. Mention how your skills align with the responsibilities listed in the job description, particularly your experience with Clinical Trial Application Forms and interactions with regulatory authorities.
Highlight Relevant Qualifications: In your application, clearly state your educational background and any advanced degrees or certifications you hold. If you have experience mentoring junior staff or using milestone tracking tools, make sure to include that as well.
Proofread Your Application: Before submitting, carefully proofread your application for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for this role.
How to prepare for a job interview at JR United Kingdom
✨Know Your Regulations
Familiarise yourself with UK regulatory and site start-up processes. Be prepared to discuss specific regulations and how they impact clinical trials, as this role heavily relies on compliance with local and international laws.
✨Showcase Your Experience
Highlight your previous experience as a Regulatory or Start-Up specialist. Be ready to provide examples of how you've successfully managed submissions and interacted with regulatory authorities in the past.
✨Demonstrate Communication Skills
Effective communication is key in this role. Prepare to discuss how you have collaborated with various stakeholders, including site CRAs and ethics committees, and how you ensure clear communication throughout the project lifecycle.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills. Think about potential risks in site activation and how you would mitigate them, as well as how you would handle unexpected challenges during the submission process.
