Regulatory Affairs Analyst & VIE page is loaded Regulatory Affairs Analyst & VIE Apply locations Barcelona time type Full time posted on Posted 30+ Days Ago job requisition id JR000073 Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.
Job Description Summary Job Description Our regulatory department is growing and we are looking for a regulatory affairs analyst VIE for a 12-month period starting in March 2024. You will be based in Barcelona and report to a Regulatory Affairs Director.
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.
Responsibilities include:
• Assist in conducting gap analyses towards applicable regulation requirements.
• Assist in managing EU regulatory intelligence.
• 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 and meetings with the 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.
DESIRED SKILLS AND EXPERIENCE
• Master in regulatory affairs, market access.
• Fluent in English.
• Excellent proficiency and experience with Microsoft Office (Word, 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.
You can find more information about VIE program on the website: https://mon-vie-via.businessfrance.fr/
Languages Education Contract Type
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Alira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle.
Why Work at Alira Health? With offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more. We welcome your passion and drive, talent and entrepreneurial spirit, sense of service and teamwork.
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