Manager, Regulatory AffairsLocation San Rafael, California Apply
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 Regulatory Affairs Manager is responsible for clinical and nonclinical aspects of domestic and international regulatory affairs to support global commercialization efforts and life-cycle management for multiple commercial programs. Exciting opportunity to join the Regulatory Clinical/Nonclinical group and gain global marketing application experience for multiple orphan products! Possibility for this position to expand scope into future preclinical/clinical development programs.
Provide clinical/nonclinical regulatory strategy and content to support preparation, submission, management and maintenance of domestic and international regulatory submissions including: INDs/CTAs and 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
Assist in coordination and preparation for global health authority meetings and associated briefing documents/presentations
Ensure compliance with existing product licenses (ie, annual reports – IND, PMR, BLA/NDA, DSUR/PBRER, RMP) fulfillment of post-marketing requirements and commitments; and maintain master CTD content
Participate/facilitate relevant functional area and project team meetings
Review documents (SOPs, protocols, and reports) related to clinical or nonclinical studies
Continues to 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
5 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)
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.