Associate I, Regulatory Clinical/Nonclinical
BioMarin 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. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development 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.
This is an entry-level position within the clinical/nonclinical regulatory affairs group. This position will support designated regional regulatory activities for assigned projects and be responsible for coordinating the preparation and execution of submissions to regulatory authorities.
- Responsible for preparing regulatory submissions for investigational and commercial products including IND/CTAs, protocol and information amendments, new investigator amendments, IND Annual Reports
- Performs workflows and procedures regarding document tracking, retrieving, and disseminating information.
- Works to develop and acquire required regulatory skills and knowledge, with mentorship from immediate manager.
- Seeks assistance from appropriate internal and external resources
KNOWLEDGE AND SKILLS
- 1-2yrs experience in Regulatory Affairs or equivalent experience in a related function.
- Basic understanding of the role of Regulatory Affairs
- Good organization skills and ability to work on several activities in alignment with timeline.
- Strong interpersonal and communication (written and verbal) skills
- Ability to travel as needed for interactions with Health Authorities or as determined by the business
- Proficiency in Microsoft Word, Excel, and Power Point,
BS degree in life sciences or equivalent
Fluent in English (written and spoken)
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.