Sr. Manager, 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.
- Come join our team and make a meaningful impact on patients’ lives.
- 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 will oversee submission planning (including scheduling and resource allocation), 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 will manage internal Regulatory Operations personnel as well as the activities of external consultants.
- The position will also oversee the development and maintenance of processes, templates, standards, and guide sheets.
- The position must be able to oversee applications and systems support (including Livelink Knowledge Management), systems training programs, and supporting development projects within Regulatory Affairs. Other duties as assigned.
- This position interacts with Regulatory Affairs and departments providing information to be submitted (including but not limited to Clinical, Nonclinical, and Quality).
- This position requires extensive knowledge of MS Office, Adobe Acrobat, Livelink and InSight Publisher.
- This position requires the ability to exercise discretion, independent judgment and clearly identify priorities, as well as to work overtime in order to meet required timelines.
- At least 5 years of experience in Regulatory Operations OR at least 4 years of experience in Regulatory Operations, InSight Publisher certification, and 3 years of related experience.
- Minimum 2-3 years of direct management experience required.
- Must be highly proficient in MS Office 2013 (with an emphasis on MS Word) and Adobe Acrobat (version XI Pro preferred). Strong knowledge of eDMS and eCTD Publishing Systems (Livelink and InSight Publisher preferred). Must have extensive experience with electronic submissions, specifically eCTD.
- The candidate should have proven ability to manage critical projects as part of an interdisciplinary team. In addition, the candidate should have experience managing major regulatory submissions, with the ability to successfully manage projects to deadlines.
- The candidate is expected to have a thorough understanding of relevant submission formatting, transmittal and archiving regulations and guidelines and to have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities. Must be able to interpret guidelines and effectively implement
- Bachelor’s Degree desirable.