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