Director/ Senior Director will responsible for the global regulatory, quality, and compliance functions at Revelation Biosciences.
Responsible for the development, implementation, and direction of effective regulatory and quality strategies. The position oversees the implementation of strategies for earliest possible approvals of marketing applications for the company's product pipeline. The position has responsibility for tracking and evaluation of governmental and international regulations and their impact relative to drug regulation. The incumbent must build and maintain excellent relationships with the FDA, other health authorities, and corporate partners while advocating the company's position.
This position is also responsible for leading the Quality Assurance team and its activities. This includes the generation and review of GMP documents, internal and external audits, and leading investigations and resolving quality issues.
Duties and Responsibilities
- Ensures regulatory milestones are met to support regulatory approval strategies and overall business goals of the company;
- Works to reduce regulatory risks associated with marketing applications and works closely with functional area teams on risk mitigation strategies;
- Serves as primary contact with the FDA and other global agencies as required;
- Plans and leads meetings with regulatory agencies;
- Defines content and directs the organization in preparation of high quality and effective regulatory submissions;
- Provides critical review of all documentation supporting regulatory submissions;
- Provides regulatory input during the development of regulatory documents;
- Leads process for developing responses to questions from agencies;
- Leads regulatory activities and provides regulatory input to the project teams;
- Maintains knowledge of pertinent regulations and guidances, interprets developments and provides recommendations to the project team and senior management team;
- Directs compliance activities including the hiring, training, supervision, and mentoring of the quality assurance team to ensure accomplishment of tasks/projects;
- Works with peers to develop standard operating procedures;
- Represents QA to various teams and/or external partners;
- Supports regulatory aspects of the promotional review/approval process, ensures compliance of promotional materials, ensures timely submission of promotional materials to OPDP;
- Ensures quality and compliance of internal and external manufacturing, packaging, labeling and quality agreements;
- Develop and guide the GMP/QA team;
- Provide CMO/CRO oversight as necessary to ensure compliance with cGMP, applicable regulations, and Quality agreements.
- Education and experience:
- Bachelor's or higher degree in a life science or relevant discipline required; RAC certification preferred
- 12+ years of in-depth regulatory strategy and submission experience in pharmaceutical and/or biotech product development
- 10+years Quality experience with GCP, GMP, GLP, GXP
- Strong experience with regulatory submissions, including documents required for INDs, NDAs, NDSs, CTAs and MAAs, supplements and briefing documents
- Working knowledge of ICH, FDA and EMA Clinical, Nonclinical and multidisciplinary guidelines plus CFR Part 312 and 314
- Strong experience with CFR Part 11, 210 and 211
- Direct experience interacting with the FDA and other regulatory agencies
- Advanced knowledge and utilization of regulations and guidances
Other skills and abilities:
- Critical reasoning skills and ability to thoughtfully assess and manage risk
- Excellent team interaction skills and ability to work successfully in cross-functional teams
- Ability to work in a dynamic environment with a high degree of flexibility;
- Independent management of complex projects;
- Experienced in management of teams;
- Excellent written and verbal communication skills.