Regulatory CMC Expert in Biologics

🌍 Remote, USA 🎯 Full-time 🕐 Posted Recently

Job Description

Regulatory Affairs Biologics Expert: Lachman Consultants, the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries, is seeking a Regulatory CMC Expert in Biologics to join its cadre of per diem consultants.

Biologic product CMC regulatory reviews for submission to FDA
Broad knowledge of Food and Drug Law and Regulation, FDA policies and guidelines, and international drug regulations; Regulations and policies related to biological products, radiolabeled monoclonal antibodies, and related products; Expert knowledge of applicable CFR regulations
Quality-by-Design / Quality Risk Management
Regulatory Submissions expert: develop
Product quality CMC regulatory submissions of biologic products, monoclonal antibodies and related biological products for Investigational New Drugs (IND), Biologic License Applications (BLAs), and post-approval products including original submissions, amendments, and supplements
Biologic research and development for monoclonal antibodies and biotechnology products
Marketing applications for biologic products; post-marketing and lifecycle management
Regulatory Strategy development as relates to regulatory requirements and expectation for biologics product marketing applications, clinical trial applications / lifecycle changes to marketed products
Breakthrough products CMC IND/BLA preparation and FDA meetings
GMP inspections of manufacturing facilities for biological drug substance/drug product manufacture
Biologic / pharmaceutical drug product quality reviews
Experienced liaison to FDA, meeting package preparation, and FDA response preparation
Regulatory pre-IND and IND package preparation
Risk Assessments based on reviews of drug substance/drug product manufacturing changes
Cell line development and engineering
Regulatory considerations in establishing clonality for cell lines
Clinical Subject Matter Expert in Regulatory Strategy and Biologics Experience a plus:
Progressive experience in evaluating and designing Clinical programs for Drugs and Biologics
Ability to design clinical/bioequivalence studies and review protocols and reports for US applications
Ability to review/support Pharmacokinetics (PK) and pharmacodynamics (PD) studies
Current understanding of FDA and rest of world compliance trends in Regulatory Affairs as relates to clinical studies for Drugs and Biologics
Experience developing communications regarding clinical programs to regulatory bodies, providing written responses and updates, attending agency meetings
Expert knowledge of FDA clinical regulations and guidance
Working knowledge of combination product regulations and guidance a plus
Expert understanding of compliance with US and EU clinical regulations and guidance a plus
Excellent written and oral communication skills
Excellent interpersonal and soft skills
Ability to solve problems using innovative techniques
Strong leadership and organizational skills