Sr. Associate, Regulatory Operations - United States
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- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Our company's Development Sciences group is responsible for everything from research and discovery to post-market clinical development.
- Development Sciences involves all bench and clinical research and the associated groups that support those endeavors.
- Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases.
- Since its foundation in 1997,our company 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 Regulatory Operations Manager with strong people management 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 regulatory submissions in both paper and electronic media to health authorities in the US, EU, CA and Rest of World.
- This position an advanced understanding of regulations and guidance associated with submissions.
- This position requires participate in sub-team meetings, volunteering for action items and participating in issue resolution.
- This position must able to answer most technical questions for many submission types.
- Must be able to troubleshoot and resolve some issues with critical computer application systems, e.g., MS Word and InSight Publisher.
- 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
- 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.
- Bachelor’s Degree desirable.