Lachman Consultant Services, Inc.
Experience. Excellence.
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.