Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

We are currently seeking a Regulatory Affairs Specialist in Brazil to join our Regulatory Affairs department focused on local submissions. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting.  

In this role you will be a pivotal team member supporting local team members within regulatory affairs in regard to submission-related activities.

You will act as a representative of the regulatory department with other departments, supporting business development, working on initiatives, and contributing to quality improvement.

The following skills are required to be successful in this position:

Support the preparation and compilation of local regulatory submissions to ANVISA related to the clinical development dossier and clinical trial applications for drugs, biologics, advanced therapies and devicesInteraction with sponsors, internal teams and regulatory agenciesReview and assess clinical trial regulatory documentsEnters and maintains trial status information relating to RA activities onto PPD tracking databases in an accurate and timely mannerEnsures the local country study files and filing processes are maintained as per PPD WPDs or applicable client SOPsParticipation in project team meetingsDevelopment and implementation of project-specific processes Attendance in meetings with local associations and participation in initiatives to foster clinical trials in Brazil

Qualifications - External

What the role requires you to have:

Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the jobKnowledge of the local and global clinical trials landscape

Knowledge, Skills and Abilities:

Excellent command of the English language (written and oral) as well as local language where applicableExcellent attention to detail and quality as well as excellent editorial/proofreading skillsExceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departmentsAdvanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologiesStrong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projectsCapable of working independently on the assigned tasksGood understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; knowledge of ICH and other global regulatory guidelinesExcellent analytical, investigative and problem-solving skills