KBI Biopharma · 15 hours ago

Senior Specialist, Regulatory

United States

Full-time

Remote

Mid Level

$78K/yr - $107K/yr

3+ years exp

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Responsibilities

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.

Qualification

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Regulatory complianceCMC authoringFDA knowledgeEMA knowledgeBiologics pharmaceuticals experienceRegulatory documentation managementCustomer service orientationTeam building skills

Required

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