Regulatory Officer
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Job Location:
Any - Mexico
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
We are looking for a Regulatory Officer to join our team in regulatory and ethics submissions of clinical studies in Mexico. You will focus on facilitating the start of research projects of novel medicinal products while taking a step further in your professional career.
Only CVs in English will be accepted
Your role:
- Prepare clinical trial submission dossiers for Regulatory Authorities
- Prepare country level patient facing documents
- Communicate with regulatory authorities 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 in Pharmacy Medicine Life Sciences or an equivalent combination of education training and experience
- Prior experience with clinical trial submissions
- Full working proficiency in English
- 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 :
Advance your career in clinical research coordinating a variety of tasks and learning new things while growing with the company.
Remote Work :
Yes
Employment Type :
Full-time
Key Skills
- Hair And Beauty
- Facilities
- IT Support
- Bank
- Asp.Net MVC
About Company
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 effo ... View more
