Junior Regulatory Affairs Associate
hace 1 semana
As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.
In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
- Full Time
- Travel: Yes
- Glassdoor Reviews and Company Rating
**Success Profile**:
Check out the top traits we're looking for and see if you have the right mix.
- Detail-Oriented
- Proactive
- Problem-Solver
- Results-Driven
- Organized
- Multi-Tasker
**Rewards**:
- **Global Impact**: We are one truly global team working together to propel each client´s journey ahead faster.
- **Balance**: We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
- **Freedom**: The ability to innovate, ask “what if” and try new solutions without fear of failure.
- **Variety**: Opportunities to work on multiple accounts - never boring
- **Management**: Strong management with depth of experience working for global health authorities.
**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.
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 openings to work the day shift 8:30am to 5:30pm as well as the afternoon shift from
**2:00pm to 10:30pm** Argentinian time.
** Qualifications**:
- Solid 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
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