Since its foundation in 1997, BioMarin has brought 6 products to market, with 7 more in the pipeline, over half a billion dollars of revenue and a global footprint in 40 countries. We are a recognized industry leader in rare disease development.
Consistent with our origins is an entrepreneurial thread, making us a dynamic pharmaceutical company with passionate employees, creating innovative strategies in order to bring lifesaving treatments to patients as quickly as possible. Our patients are at the heart of everything we stand for and we seek individuals for whom significance and contribution to improving the patients' lives is a key driver.
Our Regulatory Affairs organization, made up of a team of over 100 dedicated professionals, continues to grow.
If you are an experienced Senior Associate with solid technical skills, interested in working in an environment where you’ll have the resources and infrastructure to tangibly impact the lives of patients, we want to speak with you.
- This position’s primary focus is the formatting, publishing (including QC), transmitting and archiving of regulatory submissions in both paper and electronic media to health authorities in the US, EU, CA and Rest of World.
- An advanced understanding of regulations and guidance associated with submissions, is required.
- This position requires participation in sub-team meetings, volunteering for action items and participating in issue resolution.
- The candidate for this position should be able to answer technical questions for many submission types and must be able to troubleshoot and resolve issues with critical computer application systems, e.g., MS Word and InSight Publisher.
Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Uses professional concepts and company's policies and procedures to solve a wide range of moderate problems in imaginative and practical ways.
Bachelor’s Degree desirable.
- At least 3 years of experience in Regulatory Operations OR at least 2 years of related experience in Regulatory Operations and InSight Publisher certification.
- Must be proficient in MS Office 2013 (with an emphasis on MS Word) and Adobe Acrobat (version XI Pro preferred). Knowledge of eDMS and eCTD Publishing Systems (Livelink and InSight Publisher preferred).
- Must have experience with electronic submissions, specifically eCTD. Work with functional areas to coordinate filings and have the knowledge and experience to publish more complex submissions.
- May determine methods and procedures on new assignments.
WORK ENVIRONMENT / PHYSICAL DEMANDS
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
Describe any equipment required to perform the job.
Equipment will be provided.
List the key positions, internal and external, with which the job incumbent must interact.
The candidate must interact with personnel from Regulatory Operations, Regulatory Affairs, authoring departments (including but not limited to, Quality, Clinical, Nonclinical, etc.) and project team members from BioMarin as well as partner company(ies).