Regulatory Affairs Specialist/Officer

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/87z6o3

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Join Us as a Regulatory Affairs Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to serve as the lead over several countries/projects in providing innovative solutions, including regulatory expertise and client interface. As a Regulatory Affairs Specialist, you will be responsible for the review and approval of country- and site-level essential documents required for site activation.

The documents required for each study site and country are documented in a study-specific Essential Document Compliance (EDC) Review Checklist. Once final study documents are available, the Regulatory Affairs Specialist reviews all required essential regulatory documentation for completeness, accuracy and quality, ensuring that documentation meets applicable regulatory and study requirements and supports timely site activation. Review country essential documents for completeness, accuracy, and quality as defined by the Essential Document Compliance (RDC)



checklist.

Review site essential documents for completeness, accuracy, and quality as defined by the Essential Document Compliance (RDC) checklist. Notifies EDP Submitter via email of review outcome detailing requested revisions and/or corrected documents when deficiencies are noted. Tracks EDP review details in the applicable data tracking system.

Education and Experience Requirements: Good English language (written and oral) communication skills as well as local language where applicable Good attention to detail and quality as well as editorial/proofreading skills Good interpersonal skills to work effectively in a team environment Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects Good negotiation skills Capable of working independently with direction and exercising independent judgment Bachelor’s degree/previous experience comparable to 2+ years

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/87z6o3