Principal Regulatory Affairs Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

We are currently seeking a Principal Regulatory Affairs Specialist in Brazil to join our global Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise.

In this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and coordinating regulatory strategies for submissions in Brazil on assigned (Phase 1 to 4) clinical trials, studies and projects.

You will be part of a global team providing innovative solutions and global regulatory expertise, interacting with internal team members and, if needed, directly with clients, to provide strategic regulatory intelligence and guidance.

You will feel confident providing regulatory advice and carry 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 activities are expected 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
• Discussion about regulatory strategy for each project
• Interacting with sponsors and internal teams
• Interacting with local regulatory authorities, which includes meetings / audiences
• Review and assess clinical trial regulatory documents
• Review and assess scientific literature
• Support the bidding team by sharing local regulatory intelligence
• Attend meetings with local associations and participate in initiatives to foster clinical trials in Brazil

Qualifications

What the role requires you to have

• Bachelor's 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
• 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
• undefined
• Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• undefined
• Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
• undefined
• Great understanding of national country requirements/regulatory affairs procedures for clinical trial authorization; knowledge of ICH and other global regulatory guidelines
• undefined
• Good analytical, investigative and problem-solving skills

Working Conditions and Environment

• Remote