HimalayasHimalayas logo
PSI CROPC

Regulatory Officer

PSI CRO is a global, full-service Contract Research Organization (CRO) founded in 1995, specializing in predictable patient enrollment and on-time delivery of clinical trials across various therapeutic areas. Headquartered in Switzerland, PSI operates in over 50 countries with a strong focus on quality and client satisfaction.

PSI CRO

Employee count: 1001-5000

Brazil only

Stay safe on Himalayas

Never send money to companies. Jobs on Himalayas will never require payment from applicants.

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.

Your role:

  • Prepare clinical trial documents for Regulatory and Ethics submissions
  • Communicate with regulatory authorities and support communication with 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
  • College/University degree or an equivalent combination of education, training and experience
  • Prior experience with clinical trial submissions to ANVISA in Brazil
  • Prior experience with regulatory activities for clinical trials
  • Full working proficiency in English and Portuguese, Spanish is a plus
  • Proficiency in MS Office applications
  • Detail-oriented
  • Ability to learn, plan and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills

We offer:

  • Excellent and flexible working conditions
  • Extensive training and friendly, collegial team
  • Competitive salary and benefits package
  • Opportunities for personal and professional growth

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

PSI is a leading Contract Research Organization with more than 25 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.

About the job

Apply before

Posted on

Job type

Full Time

Experience level

Education

Bachelor degree

Experience accepted in place of education

Location requirements

Hiring timezones

Brazil +/- 0 hours

About PSI CRO

Learn more about PSI CRO and their company culture.

View company profile

We are a leading full-service global Contract Research Organization (CRO) with a key strength in predictable patient enrollment across multiple therapeutic areas. Since our founding in 1995 by Dr. Robert Reekie and Dr. Roger A. Smith, we've been dedicated to revolutionizing how clinical trials are conducted, focusing on delivering high-quality, cost-effective solutions worldwide. Our mission is to be the best CRO in the world as measured by our employees, clients, investigative sites, and vendors. This commitment is reflected in our exceptionally high repeat and referral business rates and minimal staff turnover.

Our global reach allows us to conduct clinical trials across multiple continents and in over 50 countries. We are known in the industry for our 'on-time project delivery,' a reputation we've built by investing substantial effort and medical expertise into performing quality feasibility assessments that provide accurate predictors of study timelines. In fact, over 90% of our studies finish on time or ahead of schedule. We specialize in planning and executing global pivotal registration clinical trials, particularly in complex areas like oncology, hematology, infectious diseases, gastroenterology, multiple sclerosis, and rare indications. We embrace innovation and technology, leveraging cutting-edge methodologies and data-driven insights to optimize trial design, streamline operations, and enhance patient engagement. Our robust quality management systems and adherence to the highest industry standards, including ISO 9001:2015 and ISO 27001:2013 certifications, underscore our dedication to excellence. We are proud of our contributions to advancing healthcare by helping bring life-saving therapies and treatments to market. We actively engage in research collaborations and knowledge sharing to contribute to scientific advancement.

Claim this profilePSI CRO logoPC

PSI CRO

View company profile

Similar remote jobs

Here are other jobs you might want to apply for.

View all remote jobs

54 remote jobs at PSI CRO

Explore the variety of open remote roles at PSI CRO, offering flexible work options across multiple disciplines and skill levels.

View all jobs at PSI CRO

Remote companies like PSI CRO

Find your next opportunity by exploring profiles of companies that are similar to PSI CRO. Compare culture, benefits, and job openings on Himalayas.

View all companies

Find your dream job

Sign up now and join over 100,000 remote workers who receive personalized job alerts, curated job matches, and more for free!

Sign up
Himalayas profile for an example user named Frankie Sullivan