Associate Director or Director of Regulatory Affairs and Quality Assurance6425 C

Associate Director or Director of Regulatory Affairs and Quality Assurance DermBiont is a clinical-stage biotech company with multiple active INDs, enabling several Phase 2 clinical trials. Assuming positive results, the two lead products are expected to advance to Phase 3 trials within the next year or two. These products target seborrheic keratosis and hyperpigmentation disorders of the skin. The company's goal is to become a leading developer of targeted topical therapeutics, leveraging extensive team experience to select and develop first-in-class assets with high clinical success potential, defining clear regulatory strategies, and conducting efficient clinical trials. DermBiont fosters an environment that supports and empowers employees to excel. We are seeking a highly motivated Regulatory Affairs and Quality Assurance (RA / QA) professional to join DermBiont. Currently, the company employs experienced regulatory consultants to define regulatory strategies and handle electronic filings. The RA / QA person will coordinate activities between external consultants and internal teams to create and maintain regulatory documents, ensuring compliance with all regulatory requirements. This position reports to the Senior VP of Development. Qualifications : Minimum of a BS or MS degree in a scientific discipline; Ph.D. is a plus; 4+ years of RA / QA experience. Knowledge of GLP, GCP, Pharmacovigilance (PV), ICH, FDA requirements and guidelines for small molecules; experience in drafting, interpreting, and implementing QA policies and procedures for regulatory documents and document management. Ability to assess R&D, non-clinical, and clinical documents for compliance with GLP or GCP standards and identify non-compliance issues. Self-motivated individual capable of managing multiple priorities to meet project goals, with strong leadership, problem-solving, and communication skills. Experience collaborating with internal departments, external vendors, and clients. Responsibilities : Lead regulatory documentation preparation and QA activities with internal and external teams. Oversee internal review of regulatory documents. Support QA activities such as vendor audits and site inspections. Apply knowledge of GLP, GCP, FDA, ICH, and industry standards. Assist cross-functional teams in interpreting policies, guidelines, and regulatory requirements for document production. Support SOP drafting and development. Prepare and execute regulatory submissions (e.g., IND, BLA/NDA) for global authorities like FDA and EMA. Assist with Pre-IND meetings, and review Pre-IND, IND modules, and BLA/NDA documents in coordination with SMEs and medical writers. Manage document control to ensure quality and compliance. Develop systems to ensure high-quality, reliable clinical data. Define and oversee QA activities for preclinical and clinical studies. Audit and review clinical trial documents, reconcile audit findings, and maintain records.

#J-18808-Ljbffr