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.
Security Clearance Required: No
Visa Candidate Considered: No
2+ to 5 years experience
Seniority Level - Associate
Management Experience Required - No
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally
Experience with post market or established products
Biotech/Pharma industry experience
Experience with submissions
Clin/Non-Clin, CMC or labeling experience
WHY WE'RE A GREAT COMPANYBioMarin 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.