Senior Regulatory and Start Up Specialist

Precision For Medicine; United Kingdom; Remote; GBP 50,000 - 70,000; Full time

Job summary

A leading company in the clinical research field is seeking a Senior Regulatory and Start Up Specialist to join their UK team. This fully remote role involves managing site activation processes, regulatory submissions, and ensuring compliance with local and international regulations. The ideal candidate will have a strong background in regulatory affairs within the CRO or pharma industry and excellent communication skills.

Qualifications

• At least 3.5 years as a Regulatory or Start-Up specialist in CRO or pharma/biotech industry.

Responsibilities

• Ensuring timely and quality delivery of site activation readiness.
• Preparing Clinical Trial Application Forms and submission dossiers.
• Maintaining audit/inspection readiness and proper documentation in TMF.

Skills

Communication

Organizational Skills

Fluency in English

Education

Bachelor’s degree in life sciences or related field

RN or equivalent experience

Job description

Senior Regulatory and Start Up Specialist

Precision for Medicine is not your typical CRO. We leverage new technologies, expertise, and operational scale to enhance the speed, cost, and success rate of bringing therapies to patients. Our unique approach integrates clinical trial execution with 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 team in the UK. This role can be fully remote.

Essential responsibilities include:

1. Ensuring timely and quality delivery of site activation readiness, identifying and mitigating risks.
2. Preparing Clinical Trial Application Forms and submission dossiers for CA, EC, and other local bodies, adhering to local and international regulations, SOPs, and ICH-GCP principles.
3. Interacting with CA/EC, handling submission responses, and providing regular updates to relevant stakeholders.
4. Maintaining project plans, trackers, and regulatory intelligence tools.
5. Supporting the development of start-up plans, IMP release requirements, and document review criteria.
6. Partnering with site CRAs to ensure effective communication and collaboration.
7. Managing essential documents for site activation and IMP release, including translations.
8. Communicating with key functions involved in country start-up regarding project status and deliverables.
9. Acting as SME for critical path data points to ensure on-time site activation.
10. Supporting negotiation of study budgets and investigator contracts as needed.
11. Staying updated on local clinical trial laws and regulations and disseminating this knowledge within PfM.
12. Maintaining audit/inspection readiness and proper documentation in TMF.
13. Supporting Pre-Study Site Visits and site outreach for feasibility assessments.
14. Developing country-specific start-up summaries, process flows, and training sessions.
15. Mentoring staff on local regulations, submissions, and procedures.
16. Interacting with clients for activation updates, document requests, and proposal activities.
17. Performing other duties as assigned.

Qualifications:

• Bachelor’s degree in life sciences or related field, or RN, or equivalent experience.
• At least 3.5 years as a Regulatory or Start-Up specialist in CRO or pharma/biotech industry.

Additional Requirements:

• Excellent communication and organizational skills.
• Proficiency with computerized systems, spreadsheets, and email.
• Fluency in English.
• Ability to prioritize and meet deadlines.

Preferred Qualifications:

• Experience with regulatory and start-up processes in the UK.
• Knowledge of milestone tracking tools.
• Ability to mentor junior staff.
• Advanced degrees or certifications (MD, PhD, PharmD, RAC, etc.).
• Knowledge of GCP/ICH and other regulations.
• Attention to detail, strong organizational skills, and effective communication skills.
• Ability to work independently and adapt to a fast-paced environment.
• Willingness to travel occasionally.