Regulatory Affairs Specialist

Work Schedule

Environmental Conditions

Job Description

We are currently seeking a Regulatory Affairs Specialistin 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 withinregulatory 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 devices
• Interaction with sponsors internal teams and regulatory agencies
• Review and assess clinical trial regulatory documents
• Enters and maintains trial status information relating to RA activities onto PPD tracking databases in an accurate and timely manner
• Ensures the local country study files and filing processes are maintained as per PPD WPDs or applicable client SOPs
• Participation in project team meetings
• Development 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:

• Bachelors degree or advanced degree preferred or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge skills and abilities to perform the job
• Knowledge 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 applicable
• Excellent attention to detail and quality as well as excellent editorial/proofreading skills
• Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
• Advanced computer skills including the use of Microsoft Word Excel Power Point; capable of learning new technologies
• Strong organizational time management and planning skills to create and follow timelines conduct long-range planning adapt to changing priorities and handle multiple projects
• Capable of working independently on the assigned tasks
• Good understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; knowledge of ICH and other global regulatory guidelines
• Excellent analytical investigative and problem-solving skills