Associate Regulatory and Start Up Specialist III

Precision Medicine Group; Madrid; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

An innovative company is seeking an Associate Regulatory and Start Up Specialist I / II to join their dynamic team. This entry-level role involves supporting regulatory and site startup activities, ensuring compliance with local laws, and facilitating communication with authorities. The ideal candidate will possess a strong educational background in life sciences, excellent organizational skills, and the ability to work independently in a fast-paced environment. This position offers the flexibility of being fully home-based, allowing you to contribute to life-changing therapies while enjoying a work-life balance.

Formación

• Bachelor's degree in life sciences or related field required.
• Strong communication and organizational skills are essential.
• Knowledge of regulatory processes preferred.

Responsabilidades

• Ensure timely delivery of site activation readiness.
• Prepare Clinical Trial Application Forms and submissions.
• Maintain communication with key functions involved in startup.

Conocimientos

Strong communication skills

Organizational skills

Fluency in English

Attention to detail

Ability to prioritize

Educación

Bachelor's degree in life sciences

Registered Nurse (RN)

Herramientas

Computerized systems

Spreadsheets

Word processing

Email

Descripción del empleo

Precision for Medicine is not your typical CRO. At Precision for Medicine, we have brought together new technologies, expertise, and operational scale to help the life sciences improve the speed, cost, and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial with deep scientific knowledge, laboratory expertise, and advanced data sciences.

As our organization continues to grow, we are hiring an Associate Regulatory and Start Up Specialist I / II to join our team in Spain. This position can be offered fully home-based.

Job Description

Position Summary:

The (Associate) Regulatory and Start Up Specialist I / II is an entry-level professional in regulatory and site startup activities. Responsibilities depend on the location of the RSS and include initial and subsequent clinical trial submissions to Competent Authorities and IRB/Ethics Committees, review and adaptation of Informed Consent Forms, collection and quality review of Essential Documents, supporting sites on IRB/EC submissions, and supporting the Site Contract Management group in budget and contract negotiations. The role is guided by a more senior RSS and supported by other in-country team members involved in site startup activities.

Essential functions of the job include, but are not limited to:

1. Ensuring timely and quality delivery of site activation readiness within the assigned country/sites, including risk mitigation.
2. Preparing Clinical Trial Application Forms and submission dossiers (initial and amendments) to authorities and ethics committees according to local requirements and timelines.
3. Interacting with authorities and ethics committees for study purposes and handling responses.
4. Providing updates on submissions to the Start Up Lead, Regulatory Lead, Project Manager, and team.
5. Maintaining project plans, trackers, and regulatory intelligence tools.
6. Supporting the development of startup plans, IMP release requirements, and document review criteria.
7. Partnering with site CRAs to ensure communication and collaboration.
8. Preparing and managing collection of essential documents for site activation and IMP release.
9. Customizing country/site-specific patient information sheets and consent forms.
10. Coordinating translations of documents for submissions.
11. Maintaining communication with key functions involved in country startup.
12. Tracking critical path data points for site activation, including timelines and negotiation requirements.
13. Supporting negotiation of study budgets and investigator contracts when required.
14. Participating in feasibility assessments and site outreach.
15. Staying updated on local clinical trial laws and regulations.
16. Maintaining audit/inspection readiness and filing documents per TMF plan.
17. Performing other duties as assigned.

Qualifications: Minimum Required:

• Bachelor's degree in life sciences or related field, or Registered Nurse (RN), or equivalent experience.

Other Required:

• Strong communication and organizational skills.
• Experience with computerized systems, spreadsheets, word processing, and email.
• Fluency in English and the local language of the country where based.

Preferred:

• Knowledge of regulatory and startup processes, regulations, and guidelines.
• Knowledge of GCP/ICH guidelines and regulatory requirements.
• Experience with milestone tracking tools.
• Ability to prioritize and meet deadlines.
• Attention to detail and accuracy.
• Effective communication and interpersonal skills.
• Ability to work independently in a fast-paced environment.
• Flexibility and willingness to travel occasionally.

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