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Company

Original Job Post

DermBiont, Inc. · 2 days ago

Associate Director or Director of Regulatory Affairs and Quality Assurance

Emeryville, CA

Full-time

Hybrid

Director

4+ years exp

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H1B Sponsorship

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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 and execution of regulatory submissions for assigned programs to global regulatory authorities (FDA, EMA, etc.).

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.

Qualification

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RA/QA ExperienceGLP KnowledgeGCP KnowledgePharmacovigilance KnowledgeICH KnowledgeFDA Requirements KnowledgeRegulatory Compliance AssessmentRelationship ManagementLeadershipProblem-SolvingWritten CommunicationVerbal CommunicationCollaboration

Required

BS or MS degree in a scientific discipline

4+ years RA/QA experience

Knowledge of GLP and GCP, Pharmacovigilance (PV), ICH, FDA requirements and guidelines for small molecules

Ability to assess R&D, non-clinical, and clinical documents for compliance to regulatory standards for GLP or GCP

Experienced, self-motivated individual with strong leadership, problem-solving, written, and verbal skills

Experience in managing relationships with internal departments, external vendors, and clients in a collaborative manner

Preferred

Ph.D. in a scientific discipline

Company

DermBiont, Inc.

DermBiont’s mission is to become the world’s leading precision dermatology company developing and commercializing targeted topical therapeutics that treat, cure, and prevent diseases.

Founded in 2017

Boston, Massachusetts, USA

51-200 employees

https://www.dermbiont.com/

H1B Sponsorship

DermBiont, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2022 (3)

2021 (6)

2020 (3)