Regulatory Affairs Specialist (Spain)

Indero; Madrid; A distancia; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A contract research organization is seeking a Regulatory Affairs Specialist in Madrid. The role involves preparing and submitting regulatory documentation, ensuring compliance with EU regulations, and coordinating timelines for clinical trial submissions. Candidates should have a Bachelor's degree in a scientific discipline and 2-3 years in regulatory affairs. The position offers a permanent full-time contract, a flexible schedule, and home-based work options.

Servicios

Permanent full-time position

Flexible schedule

Vacation

Home-based position

Ongoing learning and development

Formación

• Minimum of 2-3 years of clinical research experience in regulatory affairs.
• Experience in initial CTA is essential.
• Hands-on experience preparing, reviewing, and submitting regulatory documents.

Responsabilidades

• Prepare regulatory documents and submissions to ensure compliance.
• Coordinate regulatory timelines for all assigned projects.
• Serve as point of contact for Sponsors and project management teams.

Conocimientos

Excellent organization and communication skills

Fluency in English

Knowledge of GCP and ICH standards

Attention to detail

Ability to work under pressure

Versatile in multitasking

Educación

Bachelor's degree in a scientific discipline

Descripción del empleo

Overview

Due to ongoing global expansion, Indero is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for preparation and submission of part I and / or part II following EU CTR and other applications created within or outside of the company to ensure documentation comply with applicable regulations and guidelines and contractual timelines are met. You will provide leadership for assigned projects regarding all regulatory activities that lead to start up of clinical trials.

Responsibilities

• Preparation of regulatory documents, CTA packages, and submissions in assigned countries to ensure high quality standards
• Coordination of regulatory timelines and deadlines for all assigned projects planned for CTIS submissions. Includes oversight of EU (mainly), APAC, and North America submissions.
• Review of regulatory documents and submissions created outside of the company by subcontractors (e.g., partner CROs, regulatory vendors) to ensure high quality standards before submission to CTIS
• Point of contact for Sponsors and subcontractors / project management teams for all aspects related to study regulatory submissions
• Preparation or review of country specific Patient Information Sheet / Informed Consent form documents.
• Preparation or review of study-specific templates of regulatory forms.
• Manages translation requests with vendors.
• Regulatory support and advice to project teams and key internal / external customers on local requirements and EU submission strategy and technical expertise
• Maintain high level knowledge about EU CTR and EU / EEA countries local requirements in the area of company interest.
• Maintain the regulatory intelligence database
• Participation in Kick-off meetings, audits, and other project related meetings according to the company / client needs

Our company: The work environment

At Indero, you will work with brilliant and driven professionals. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

As a Regulatory Affairs Specialist you will be eligible for the following perks :

• Permanent full-time position
• Flexible schedule
• Vacation
• Home-based position
• Ongoing learning and development

About Indero

Indero is a contract research organization (CRO) specialized in dermatology and Rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Spain.

Brand name : Indero

Education

• Bachelor\'s degree (or equivalent) in a scientific discipline

Experience

• Minimum of 2-3 years of clinical research experience (in CRO or Pharma) working in Poland regulatory affairs is required
• Experience in initial CTA is essential
• Experience in a sponsor facing role is an asset
• Previous experience with CTIS is an asset
• Hands-on experience preparing, reviewing, and submitting regulatory documentations

Knowledge and skills

• Excellent knowledge of applicable EU regional / national country regulatory guidelines (such as Poland, Spain, Germany, France, Netherlands)
• Excellent knowledge of GCP and ICH standards
• Fluency in English with excellent oral and written skills, required
• Additional languages represent an asset
• Excellent organization and communication skills, great attention to detail
• Ability to organize own work, prioritize different assignments, and work under pressure;
• Versatile and comfortable in a multitasking environment;
• Respect established timelines, expectations, priorities, and objectives;