Organization:
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.
Overview:
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:
- Lead regulatory documentation preparation and quality assurance (QA) activities with internal and external team members.
- Responsible for overseeing the internal review of all regulatory documents.
- Support Quality Assurance (QA) related activities (e.g., vendor audit, site inspection).
- Provide knowledge of GLP and GCP, US Food and Drug Administration (FDA), International Council for Harmonization (ICH), Global Pharmacovigilance (GPV), regulations, guidelines, and industry standards.
- Assist cross-functional teams on interpretation of policies, guidelines, and regulatory requirements to support regulatory document production.
- Support phase appropriate SOP drafting and development.
- Support the preparation (including authoring where relevant) and execution of regulatory submissions for assigned programs to global regulatory authorities (FDA, EMA, etc.).
- Support and assist with Pre-IND meetings, IND, and BLA/ NDA regulatory submissions, writing and reviewing of Pre-IND documents, IND modules and BLA/NDA documentation in coordination with SMEs, medical writing teams, and publishers.
- Manage document control activities to ensure quality system documents are reviewed, approved, maintained, and controlled.
- Assist in the development and implementation of systems and programs to ensure a high level of quality, integrity, and robustness of generated clinical data.
- Define and manage phase appropriate QA activities in support of preclinical studies and clinical trials.
- Audit and review clinical trial documents, reconcile audit results from multiple sources, and maintain audit records.
