Manager, Regulatory Affairs
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.
The Manager in Regulatory Affairs, Clinical/Nonclinical, will be responsible/accountable for:
- Preparing clinical/nonclinical global regulatory submissions in accordance with applicable regulations, including the following:
- INDs or international equivalents and amendments
- NDAs, BLAs, or international equivalents and amendments
- Information related to clinical trials including protocols, investigator brochures and investigator information
- Annual Reports
- Representing the Regulatory Affairs function on assigned cross-functional project teams and to external partners
- Actively participate in regulatory sub-teams and lead meetings on defined topics with a clear objective
- Researching and interpreting global regulations to provide regulatory guidance to cross-functional groups
- Proactively identify and communicate potential regulatory issues/risks and recommend solutions to Regulatory Affairs management
- Assist in coordination of meetings with Regulatory Authorities and associated briefing document preparation, as needed
- Other duties as assigned
- 3-4 years of experience in Regulatory Affairs or related discipline in the pharmaceutical or biotechnology industry, preferably with exposure to the development phase of the product lifecycle
- Experience in management and submission of clinical/nonclinical global regulatory documents
- Experience in participating and representing Regulatory Affairs on clinical study management teams
- Thorough understanding of relevant clinical/nonclinical ICH and regional regulatory requirements, particularly for the development phase of product development
- Excellent communication (verbal and written) and interpersonal skills with the ability to communicate cross-functionally in a collaborative manner
- Attention to detail
BA/BS degree in life sciences required. Advanced degree preferred.
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.