Director, Regulatory Affairs Commercial ProgramsLocation San Rafael, California
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. The Global Regulatory Affairs group plays an integral role in the development and commercialization of 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!
BioMarin is seeking a Regulatory professional focused on clinical and nonclinical aspects of domestic and international regulatory affairs to support global commercialization efforts and life-cycle management for multiple commercial programs. This is an exciting opportunity to join the Regulatory Clinical/Nonclinical group and gain global marketing application experience for multiple orphan products!
- Develop clinical/nonclinical regulatory strategy and lead the preparation, submission, management and maintenance of domestic and international regulatory submissions including: IND/CTA amendments; global Marketing Applications (MAs) and amendments/supplements; Orphan drug applications; Expedited review requests; Post-marketing requirements/commitments and Annual Reports.
- Provide strategic regulatory insight on clinical/nonclinical aspects of programs and ensure implementation of regulatory concepts within the global regulatory team and cross-functional project teams
- Advise/lead development of clinical/nonclinical content (ie, associated briefing documents/presentations) to support global health authority meetings in partnership with Regulatory regional leads and GRL
- Management of 1-2 Regulatory contractors
- Ensure compliance with existing product licenses (ie, annual reports – IND, PMR, BLA/NDA, DSUR/PBRER) and fulfillment of US post-marketing requirements and commitments; and maintain clinical/nonclinical master CTD content as needed
- Participate/facilitate relevant functional area and project team meetings
- Review documents (SOPs, protocols, and reports) related to clinical or nonclinical studies
- Expand knowledge base of laws, regulations, and guidelines governing the development, licensure, and marketing of drugs and biologics
- Exercise discretion and independent judgment in the performance of the above duties
- 7-10 years of industry experience in Regulatory Affairs or a related discipline in the pharmaceutical or biotechnology industry with a clinical and nonclinical emphasis
- Skilled at gathering regulatory information and developing product approval strategies
- Proven track record of managing critical projects as a part of an interdisciplinary team
- Proven track record of successfully interacting with regulatory health authorities
- Prior experience managing regulatory submissions to deadlines
- Thorough understanding of relevant drug development regulations and guidelines
- Outstanding interpersonal and communication (written and verbal) skills
- Effective task planning and coordination abilities
- Proficiency with computer and standard software programs (Microsoft Office, PowerPoint and Excel)
- Experience managing a small team or at a minimum management in a matrix setting
- Rare disease experience is desirable
- Prior experience in the metabolism or endocrinology therapeutic areas is desirable
- BA/BS degree in life sciences
• Advanced degree a plus
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.