Our client is seeking a Regulatory Generalist to support various functions related to international product renewals, manufacturing transfers to new facilities, and international regulatory filings. The client has tissue products that are classified differently across the globe based on local notified body requirements. As their product is improved and the manufacturing process is changed, those filings need to be updated and some require changes from Device filings to a BLA or from a tissue to a pharma product. This consultant will be fulfilling a variety of tasks including regulatory writing, submission work, coordinating operations for compliance and product release, and product renewals. There are deadlines for renewals in countries worldwide that will be the immediate need before moving into MAA, BLA filings, and Dossier filing. The ideal candidate will have 15+ years of regulatory experience including writing, international submissions, packaging/ad-promo compliance, and a strong blend of strategic/tactical capabilities.
- Regulatory, international filings, EMA, Veeva RIM, BLA Filing, MAA, Device-Pharma-Biologic
- Experience outweighs degree
Remote: Regulatory Generalist (234154)