Regulatory Affairs Specialist-Romania

Description

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 (eg, 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 Romania 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

Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmac