Director, Regulatory Affairs (Device) - San Diego, California

We’re a different kind of biotech company. And we’re here to make a difference.

Prometheus Biosciences, Inc. (Nasdaq: RXDX), is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases.

The Company’s precision medicine platform, Prometheus360™, combines proprietary machine learning-based analytical approaches with one of the world’s largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets. Headquartered in San Diego, Prometheus Biosciences, Inc. was named Best Places to Work by BioSpace, San Diego Business Journal and is a Great Place to Work-Certified™ Company.

Summary

The Director of Regulatory Affairs is responsible for providing a global regulatory strategy and support as a member of multi-disciplinary drug and device teams.Manage processes from development through to approval and ensure compliance with all US and international regulatory requirements.

Key Duties and Responsibilities

• Represent Regulatory Affairs in assigned project meetings and provide regulatory guidance to cross-functional project teams as appropriate; leverage experience in device regulatory affairs to provide guidance to colleagues for preparation of regulatory documents
• Serve as regulatory contact for external parties (for example, CROs, advisors) involved in the conduct of Prometheus Biosciences’ global clinical trials with devices
• Develop and implement global regulatory strategy for device submissions to support clinical trials and registration in accordance with applicable regulations/guidelines (for example,US FDA, EMA, PMDA, ICH, ISO)
• Plan, prepare, author, and/or review documentation and submissions (for example,IND, CTA, BLA, NDA, MAA, IDE, 510k, PMA) to Health Authorities to support clinical trials, registration, maintenance of registration, and labeling of pharmaceutical products
• Communicates with Health Authorities when required
• Contribute to the development of competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risks
• Communicate project updates and risks to senior regulatorymanagement and stakeholders across the organization
• Tracking regulatory commitments and deliverables while coordinating with internal and external staff to ensure timely submissions
• Coordinate and prepare responses to requests for information from Health Authorities
• Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities
• Provide input into the development of internal policy and procedures for Regulatory Affairsin alignment with GxPs, QSRs, guidance documents, and corporate objectives
• Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
• Participate in due diligence evaluations of potential in-license/partnering opportunities

Education and Experience

• Education equivalent to a BS degree in a scientific field, plus 15 years of experience in Regulatory Affairs; or
• Education equivalent to an MS degree in a scientific field, plus 13 years of experience in Regulatory Affairs; or
• Education equivalent to a Ph.D./PharmD degree in a scientific field, plus 10 years of experience in Regulatory Affairs
• Experience with class II-III biologics experience preferred
• Regulatory Affairs experience with multiple therapeutic modalities;emphasis on biologics, drug/device combination products, and in vitro diagnostic devices

Essential Skills and Abilities

• Unquestionable integrity, be able to inspire trust and exhibit the highest ethical standards
• Excellent communication, verbal and written, and interpersonal skills with a strong ability to interact with internal teams and partners across all levels of the organization
• Ability to effectively present information and respond to questions from all levels of the organization
• Sense of urgency, flawless execution with an intense focus on accuracy and accountability
• Self-starter, highly motivated, assertive, driven, and hands-on leader
• Ability to multi-task in a fast-pacedenvironment
• Operate collaboratively with colleagues across functional areas in ascience-driven environment
• Ability to work well under pressure and meet time-sensitivedeadlines
• Ability to work across locations and time zones
• Highly proficient using Microsoft Word, Excel, PowerPoint, Adobe, and SharePoint; or similar applications and systems; experience with Veeva is a plus
• Strong financial business acumen and analytical skills; ability to develop and manage expenditures in accordance with budget

• Travel up to 10% may be requiredto meet with vendors andregulators

The anticipated base pay range for this position is $85,000 to $285,000. Individual pay is determined by job-related skills, experience, and relevant education or training.