BioMarin Career Opportunity
Join us in delivering therapeutics that provide meaningful advances to patients with serious and life-threatening rare genetic diseases.
About BioMarin
We are the world leader in this field, targeting 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.
Our Focus
We will continue to focus on advancing therapies that are the first or best of their kind. Our Research & Development group is responsible for everything from research and discovery to post-market clinical development.
Responsibilities
* Act as the primary regulatory CMC contact at the BIL site, comprising end to end manufacturing of biologicals.
* Work closely with the BioMarin International Ltd (BIL) Quality assurance, Quality Control and Manufacturing groups to assure relevant product and regulatory expectations are met.
* Manage a small team of regulatory CMC professionals at the BIL site.
* Brand the excellent work of the BIL regulatory team at BIL site meetings and at global regulatory meetings.
* Primary regulatory CMC contact with contract manufacturing organizations (CMOs) based in Europe, as required.
* Lead global marketing authorisations, renewals and post-approval changes for biological products, drug-device combination products and/or small molecules.
Requirements
* Minimum requirement is for a bachelor's degree in a pharmacy, biological discipline, chemistry, or molecular biology or other science.
* Minimum of 8 years of Regulatory Affairs, CMC experience.
* Proven experience in a leadership role with strong management skills and business acumen.
* Experience with people management preferred.
* Understanding of drug development, technology transfers and working under accelerated timelines.
* Outstanding interpersonal and communication (written and verbal) skills is required.
* Strong writing and editing skills for technical documentation.
About Us
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.