Senior Specialist - Regulatory

September 20

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Description

• Responsible for regulatory compliance as it relates to contract manufacturing and analytical services. • Responsible for the coordination and evaluation of regulatory activities. • Perform various activities for CMC authoring and review in support of client filings. • Consult with clients on regulatory topics and support regulatory inspections from health authorities. • Other responsibilities include providing letters of authorization to clients for referencing KBI biopharma’s facility DMF, compiling and updating Site Master Files (Facility Drug Master File Documents), and annual updates to facility registrations. • Lead CMC writing and review for Sponsors, utilize internal resources as needed to draft, review, and edit CMC sections of Sponsor’s filings. • Maintain all Regulatory Documentation to include LOA, Compliance Letters, Permits, and update all RA Share Points and Databases. • Interact with Clients and Agencies regarding Regulatory Topics. • Work with our publishing vendor to publish all RA documents to the appropriate agencies and within specified timeframes.

Requirements

• Relevant degree and minimum 3 years relevant work experience in biologics pharmaceuticals, other health regulated industry or experience working for a health authority. • Experience with FDA, EMA, and knowledge of regulatory requirements with emphasis on regulatory requirements for biotechnology derived products. • Strong orientation for attention to detail, regulatory compliance, and customer service. • Excellent writing and verbal communication skills. • Demonstrated level of respect for individuals. • Demonstrated contribution to science in appropriate area. • High level of integrity and personal responsibility. • Record of innovation. • Strong collaboration and team building skills. • Independent project leadership.