Junior Regulatory Affairs Associate

GREAT OPPORTUINITY to join a G-R-O-W-I-N-G Team!

We are currently recruiting bi-lingual (English and Spanish) Junior Associates to join Parexel’s Regulatory Operations Team in our Buenos Aires office. Our Regulatory Operations Services include both pre-approval and post-approval activities ranging from the compilation, publishing, and dispatching of large regulatory dossiers to the authoring of routine product variations, annual reports and other product lifecycle maintenance tasks.

Do you have solid experience in document publishing and QC? Are you interested in working in a large global clinical research organization? We are looking for strong candidates who will have the ability to interact professionally within an international organization. In this role you will assist in the production of submissions and delivery of regulatory services in accordance with defined agency guidelines while balancing the quality and timeliness of customer deliverables. Under the general direction of a Project Lead, you will be responsible for ensuring that client work is performed, and delivered on time, meeting the quality expectations of Regulatory Outsourcing Services and the client.

You must have experience in document publishing ideally using Adobe Acrobat bookmarks and hyperlinks as well as submission preparation and QC using Insight Publisher.

Preference will be given to those with a related University degree.

Fluency in written and spoken English is required.

Due to Parexel's global presence and global clients, our Regulatory Operations Team works shifts. We currently have an opening to work the afternoon shift from 2:00pm to 10:00pm Argentinian time.QualificationsSolid experience with MS Office suite and Adobe Acrobat. Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline ie. Computer Translation Fluency in written and spoken English and Spanish Previous eCTD submission preparation experience is a plus as is QC experience using Insight Publisher