Associate Director or Director of Regulatory Affairs and Quality Assurance6425 Christie Avenue, Emeryville, CA

Associate Director Or Director Of Regulatory Affairs And Quality Assurance

DermBiont is a clinical stage biotech company with multiple active INDs enabling multiple Phase 2 clinical trials. Assuming positive results in the current trials the two lead products will advance to Phase 3 trials in the coming year or two. The two lead products are for the treatment of seborrheic keratosis and for the treatment of hyperpigmentation disorders of the skin. The company aims to be the leading targeted topical therapeutics development company. This is facilitated by leveraging decades of combined team experience to select and develop first-in-class assets with the highest probability of success in the clinic, defining clear regulatory strategies, and conducting efficient clinical trials. DermBiont works continually to create an environment that supports and empowers our employees to do their best work.

We are seeking a highly motivated Regulatory Affairs and Quality Assurance (RA / QA) experienced professional to join DermBiont. Currently, the company is employing highly experienced regulatory consultants to help define the regulatory strategy and to submit electronic regulatory filings. The RA / QA person will be responsible for the coordination of the activities of the external consultants and internal team members to create and maintain the required regulatory documents and ensure that the company meets all regulatory requirements. This position will report to the Senior VP of Development.

Qualifications :

• Have at minimum a BS or MS (Ph.D. not required but would be a plus) degree in a scientific discipline and 4+ years RA / QA experience.
• Knowledge of GLP and GCP, Pharmacovigilance (PV), ICH, FDA requirements and guidelines for small molecules, including drafting, interpreting, and implementing quality assurance policies and procedures for regulatory documents, as well as establishing document management activities.
• Ability to assess R&D, non-clinical, and clinical documents for compliance to regulatory standards for GLP or GCP and to identify areas of non-compliance.
• Experienced, self-motivated individual who can handle multiple priorities to meet project team goals and timelines, with strong leadership, problem-solving, written, and verbal skills, and the ability to communicate clearly, concisely, and effectively.
• Experience in managing relationships with internal departments, external vendors, and clients in a collaborative manner.

Responsibilities :