Our regulatory department is growing and we are looking for a regulatory affairs analyst intern for a 6-month period starting in September 2021. You will be based in Barcelona and report to the VP Regulatory Affairs.
As a Regulatory Affairs analyst, you will work on client projects as part of a team and be responsible for problem solving. You will play a key role in gathering and analyzing data and documentation, and in contributing to the team’s recommendations.
ESSENTIAL JOB FUNCTIONS
- Conduct gap analyses towards applicable regulation requirements
- Identify issues and help form hypotheses and solutions to address client questions.
- Work with team to synthesize findings and refine recommendations.
- Develop and edit slide presentations or other communications to convey insights and recommendations of team.
- Keep up to date information on submission and pre-submission requirements and options
- Support in the preparation of clinical trial application
- Assist in the preparation of packages for regulatory agencies
- Support the collection of materials for pre-submission reports, preclinical and clinical studies when needed
- Assist in the preparation business proposals, presentations, and marketing materials.
PREPARATION, KNOWLEDGE, SKILLS, AND ABILITIES
- Master in regulatory affairs, market access
- Fluent in English.
- Excellent proficiency and experience with Microsoft Office (Excel and PowerPoint are a must)
- Strong analytical and organizational skills, strong attention to detail.
- Excellent interpersonal, written communication, time management, and organizational skills
- Ability to work independently and prioritize tasks.
- Healthcare, engineering or Life Sciences studies and/or meaningful past experience in these areas is strongly desirable.