Principal Reg Affairs Specialist

Work Schedule

Environmental Conditions

Job Description

We are currently seeking a Principal Regulatory Affairs Specialistin Brazil to join our Regulatory Affairs department. 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 withregulatory affairs responsibilities leading discussions and coordinating regulatory strategies both locally and globally on assigned (Phase 1 to 4) clinical trials studies and projects.

You will be part of a global team providing innovative solutions and global local regulatory expertise providing strategic regulatory intelligence and guidance.

You will feel confident providing regulatory advice and carrying out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients.

You will act as a representative of the regulatory department with other departments supporting business development working on initiatives and contributing to quality improvement. You will also arrange lead and report on regulatory agency meetings as a local expert.

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

• Preparation assembly and review 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
• Support to the bidding team by sharing local regulatory intelligence
• Development and implementation of project-specific processes
• Attendance of 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 and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
• Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines
• Excellent analytical investigative and problem-solving skills