Senior Regulatory and Start Up Specialist

JR United Kingdom; United Kingdom; Remote; GBP 50,000 - 70,000; Full time

Job summary

A leading company in the clinical research industry is seeking a Senior Regulatory and Start Up Specialist to join their UK team. This role involves ensuring timely site activation, preparing regulatory submissions, and collaborating with various stakeholders. The position offers the flexibility of remote work, making it ideal for candidates with experience in the CRO or pharma/biotech sectors. The successful candidate will have a strong background in regulatory processes and excellent communication skills.

Qualifications

• At least 3.5 years of experience in CRO or pharma/biotech.
• Experience with UK regulatory and site start-up processes.

Responsibilities

• Ensure timely delivery of site activation.
• Prepare Clinical Trial Application Forms for regulatory authorities.
• Maintain audit and inspection readiness.

Skills

Communication

Organizational Skills

Attention to Detail

Education

Bachelor’s degree in life sciences

Tools

Computerized Systems

Spreadsheets

Job description

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Senior Regulatory and Start Up Specialist, United Kingdom

Job Description:

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:

1. Ensuring timely and quality delivery of site activation within designated countries/sites, anticipating and mitigating risks.
2. 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.
3. Interacting with regulatory authorities and ethics committees, managing responses.
4. Providing updates on submissions to relevant project leads and teams.
5. Maintaining project plans, trackers, and regulatory intelligence tools.
6. Supporting the development of start-up plans, IMP release requirements, and document review criteria.
7. Collaborating with site CRAs to ensure effective communication and site collaboration.
8. Managing collection of essential documents for site activation and IMP release.
9. Customizing patient information and consent forms for specific countries/sites.
10. Coordinating translations of submission documents.
11. Communicating with key functions involved in country start-up processes.
12. Acting as SME for critical path data points to ensure on-time site activation.
13. Supporting budget negotiations and investigator contract execution as needed.
14. Staying updated on local clinical trial laws and regulations, sharing knowledge within PfM.
15. Maintaining audit and inspection readiness, filing documents per TMF plan.
16. Supporting pre-study site visits and feasibility assessments.
17. Developing country-specific start-up summaries and process flows.
18. Training staff and mentoring on local start-up regulations and procedures.
19. Interacting with clients for status updates and document reviews.
20. 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.

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