THE OPPORTUNITY:

Avantor is looking for a strategic and results-driven Lead/ Regulatory Specialist for the Regulatory Affairs/ Product Compliance organization. The successful candidate will support both the Medical Device and Biopharma sectors.
This role is full-time, USA (northeast preferred) - Remote.

MINIMUM EDUCATION:

• Bachelor’s Degree (Biology, Pharmacy, Chemistry, Biochemistry, Biomedical Engineering, Legal Studies, Public Health Administration, Medical/Scientific Writing, or related).

REQUIRED EXPERIENCE (2+ YRS):

• In a regulated industry (IE: pharmaceutical, medical device).
• With ICH Q7, IPEC, and/ or 21 CFR 820.

PREFERRED EXPERIENCE:

• With US Drug Master File, Canadian Master File, China Registration, and other international regions.
• Working with state regulations for regulatory block release.
• Business level leadership skills.
• Being responsible for the development & maintenance of related SOPs and best practices.
• Project Management experience.
• With GMP manufacturing, compendial compliance, validations, impurities analysis, stability, and/or general auditing experience.

• Prescription Medical Device Regulatory Operations
• Biopharma Dossier and Customer Suppor