Country Approval Specialist / Regulatory Officer at PSI CRO

Raanana, Center District, Israel -

Full Time

Start Date

Immediate

Expiry Date

09 May, 26

Salary

0.0

Posted On

08 Feb, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Submissions, Ethics Submissions, Clinical Trial Dossiers, Regulatory Authorities Communication, Ethics Committees Communication, Translation Review, Documentation Flow Tracking, Safety Reporting, Regulatory Training, Feasibility Research, Business Development, Detail-oriented, Communication, Collaboration, Problem-solving

Industry

Pharmaceutical Manufacturing

Description

Company Description PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career. Office-based role in Ra'anana , Israel You will: Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters Review translations of essential documents subject to clinical trial submission Track the regulatory project documentation flow Review documents to greenlight IP release to sites Manage safety reporting to authorities Deliver regulatory training to project teams Assist with feasibility research and business development requests Qualifications College/University degree or an equivalent combination of education, training and experience. Life science degree is a plus Prior experience of at least one year with clinical trial submissions in Israel within the CRO or Pharmaceutical industries Full working proficiency in English and Hebrew Proficiency in MS Office applications and `Matarot’ software Detail-oriented Ability to learn, plan and work in a dynamic team environment Communication, collaboration, and problem-solving skills *Please send your CV in English Additional Information We offer: Excellent working conditions Extensive training and friendly team Competitive salary and benefits package Opportunities for personal and professional growth Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

Responsibilities

The specialist will prepare clinical trial submission dossiers for Regulatory and Ethics Authorities and manage communication with these bodies, project teams, and vendors regarding regulatory matters. Responsibilities also include reviewing essential document translations, tracking regulatory documentation flow, managing safety reporting, and delivering regulatory training.