At BioMarin, we are a 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.
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.
Key Responsibilities:
* Act as the primary regulatory CMC contact at the BIL site comprising end-to-end manufacturing of biologicals (drug substance, drug product, QC testing, and packaging operations).
* 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 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 authorizations, renewals, and post-approval changes for biological products, drug-device combination products, and/or small molecules.
This role includes compilation of all necessary documentation for global regulatory submissions. Ensure submissions and responses to regulatory questions are of high quality and right first time; that content and format of regulatory submissions comply with application regulations and guidance governing the development, licensure, and marketing of drugs, biologics, and/or gene therapy medicinal products.
Lead regulatory CMC support for impact assessment to change control, deviation, and cGMP inspection readiness at BIL site. Coordinate and track regulatory commitments related to drug substance and drug product technology transfers.
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 required.
* Strong writing and editing skills for technical documentation.
* Proficient with computer and standard software programs.