Senior Regulatory and Start Up Specialist

Precision Medicine Group; United States; Remote; USD 70,000 - 110,000; Full time

Job summary

An established industry player seeks a Senior Regulatory and Start-Up Specialist to enhance the efficiency of clinical trials. This fully remote role involves managing site activation, ensuring compliance with regulatory standards, and collaborating with various stakeholders. You'll be at the forefront of clinical research, utilizing your expertise to navigate complex regulatory landscapes while mentoring junior staff. Join a forward-thinking organization that values innovation and offers a supportive environment where your contributions make a significant impact on the speed and success of bringing therapies to patients.

Qualifications

• 3.5+ years experience as a Regulatory or Start-Up specialist in CRO or pharma/biotech.
• Proficiency in managing regulatory submissions and compliance.

Responsibilities

• Ensure timely delivery of site activation readiness, identifying risks.
• Prepare Clinical Trial Application Forms and submission dossiers.

Skills

Regulatory Compliance

Project Management

Communication Skills

Organizational Skills

Fluency in English

Education

Bachelor's degree in life sciences

Advanced degrees or certifications (MD, PhD, etc.)

Tools

Milestone Tracking Tools

Information Systems

Spreadsheets

Job description

Precision for Medicine is not your typical CRO. We combine new technologies, expertise, and operational scale to help the life sciences sector improve the speed, cost, and success rate of bringing therapies to patients. Our unique approach integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences.

Position: Senior Regulatory and Start Up Specialist (UK)

This role can be fully home-based.

Essential Functions:

1. Ensure timely and quality delivery of site activation readiness, identifying and mitigating risks.
2. Prepare Clinical Trial Application Forms and submission dossiers for regulatory authorities, ethics committees, and other bodies, ensuring compliance with local and international regulations.
3. Interact with regulatory authorities and ethics committees, managing responses and updates.
4. Maintain project plans, trackers, and regulatory intelligence tools, updating leadership regularly.
5. Develop start-up plans, IMP release requirements, and document review criteria.
6. Collaborate with site CRAs to ensure communication alignment and site collaboration.
7. Manage essential documents for site activation and IMP release.
8. Customize and coordinate translations of study documents.
9. Communicate with key functions on project status and deliverables.
10. Act as Subject Matter Expert for site activation data points and timelines.
11. Support budget negotiations and investigator contract execution as needed.
12. Stay updated on local clinical trial laws and regulations, sharing knowledge within the organization.
13. Maintain audit and inspection readiness, filing documents as per plans.
14. Support pre-study site visits and feasibility assessments.
15. Assist in developing country-specific start-up summaries and training sessions.
16. Mentor staff on local regulations and procedures.
17. Engage with clients for activation updates, document requests, and proposals.
18. Perform other duties as assigned.

Qualifications:

Minimum Required:

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

Other Requirements:

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

Preferred:

• Experience with UK regulatory and start-up processes.
• Use of milestone tracking tools.
• Ability to mentor junior staff.
• Advanced degrees or certifications like MD, PhD, PharmD, RAC, or Regulatory Science.
• Knowledge of GCP/ICH guidelines and other regulations.
• Attention to detail, organizational skills, and effective communication in English and local language.
• Ability to work independently in a fast-paced environment.
• Willingness to travel occasionally.

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