PSI CRO

Regulatory Officer

PSI CRO  •  Belgrade, RS (Onsite)  •  7 days ago
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Job 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 position

Your role:

  • Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, including Import and Export license applications
  • 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
  • Prior experience with clinical trial submissions is required
  • Full working proficiency in English and Serbian
  • Proficiency in MS Office applications
  • Detail-oriented
  • Ability to learn, plan and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills

Additional Information

We are currently looking for a knowledgeable, self-motivated and proactive person to join our Regulatory Affairs Department at PSI Serbia.

PSI CRO

About PSI CRO

PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.

PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.

PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.

PSI’s reputation is that of a 'no-nonsense'​ CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.

http://www.psi-cro.com

Industry
Chemicals & Materials
Company Size
1,001-5,000 employees
Headquarters
Zug, CH
Year Founded
Unknown
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