Principal Reg Affairs Spec

In this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and coordinating regulatory strategies 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 regulatory expertise, being client interfacing 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 client and regulatory agency meetings.

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

• preparation and assembly of global regulatory submissions

• interacting with sponsors,

• review and assess clinical trial regulatory documents,

• review and assess scientific literature.

• manages project teams and preparation

• participate in launch meetings, review meetings and project team meetings.

Optional skills:

• Experience with bid defense meetings

Qualifications - External

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 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