Regulatory Affairs Specialist (Spain)

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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 vendor

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

Requirements

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

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.

Location : Madrid, Community of Madrid, Spain

Note : Referrals increase your chances of interviewing at Indero (formerly Innovaderm) by 2x

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