Regulatory CMC Expert in Biologics

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. Qualifications / Responsibilities include:• 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 skillsEducational Requirements include:• M.S.(M.D. or Ph.D. preferred) life sciences and 10 years’ experience. Apply to: Apply tot his job