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 Senior Associate, Regulatory Affairs, 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 support for 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.
Assist with development of strategy 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) and fulfillment of 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
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
3 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 contributing to product approval strategies
Proven track record of managing critical projects as a part of an interdisciplinary team
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.
Additional Salary Information: Annual Bonus +RSU grant
Internal Number: 20792
About BioMarin Pharmaceuticals
BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and rare medical conditions. The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme® (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme® (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan® (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and Firdapse™ (amifampridine), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Product candidates include BMN-110 (N-acetylgalactosamine 6-sulfatase), formally referred to as GALNS, which successfully completed Phase III clinical development for the treatment of MPS IVA, PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU, BMN-701, a novel... fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is currently in Phase I/II clinical development for the treatment of Pompe disease, BMN-673, a poly ADP-ribose polymerase (PARP) inhibitor, which is currently in Phase I/II clinical development for the treatment of genetically-defined cancers, and BMN-111, a modified C-natriuretic peptide, which is currently in Phase I clinical development for the treatment of achondroplasia. BioMarin is growing rapidly to support the development and global commercialization of breakthrough drugs to treat rare genetic diseases. Join our extraordinary team and help us make it happen. BioMarin offers a friendly, fast-paced, collegial environment where success is measured by both the individual and collective efforts of hundreds of talented scientists, business professionals, technical specialists and experts in a variety of fields from sales and marketing, to finance, to manufacturing, to clinical and regulatory operations. You can make it happen at BioMarin, where the unique combination of big-company success in a small-company environment provides unparalleled opportunity for individual contributions and growth.