Regulatory Compliance Specialist

1 week ago


Wilmington, North Carolina, United States KBI BioPharma Full time
Job Summary:

As a Senior Specialist, Regulatory at KBI Biopharma, you will be responsible for ensuring regulatory compliance in contract manufacturing and analytical services. This includes coordinating and evaluating regulatory activities, performing CMC authoring and review, and consulting with clients on regulatory topics. Additionally, you will support regulatory inspections from health authorities and provide letters of authorization to clients for referencing KBI biopharma's facility DMF.

Key Responsibilities:

Lead CMC writing and review for Sponsors, utilizing 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. Additionally, a demonstrated track record in the following key areas:
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.

Salary: $77,597.00-$106,696.00

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