Manager, Regulatory Affairs - San Diego

Manager, Regulatory Affairs - 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

We are currently seeking a Manager, Regulatory Affairs to join our team. This individual will assist in overseeing the day-to-day regulatory activities for assigned clinical programs and provide oversight to relevant CROs and consultants in conjunction with the regulatory leadership. A strong team player who can communicate and collaborate in an interdisciplinary environment is essential.

Key Duties and Responsibilities

• Assist with the coordination, review, and preparation of clinical trial applications (CTAs) and amendments, ensuring compliance with the Food and Drug Administration (FDA) and international regulations and interpretations
• Support global regulatory submission activities associated with generating electronic submissions
• Contribute to submission planning in order to identify pending submissions and to define priorities
• Perform quality control verifications and coordinate comments resolution with the publishing team
• Support subject matter expert authors to complete regulatory documents such that all components are provided and presented in the correct format
• Manage document review and approval as needed
• Support the regulatory strategy, coordination, preparation, and submission of regulatory documents such as quality information, responses to requests for information from health authorities, meeting packages, and dossiers for health authority approvals
• Alert regulatory management to issues and potential problems, delays, and/or deficiencies on planned submissions and make recommendations as appropriate
• Coordinate with the electronic submissions vendor to ensure high-quality standards for timely and accurate delivery of all FDA submissions
• Maintain and index the regulatory interactions archive (FDA and other international health authority submissions and correspondence)
• Support the development and implementation of regulatory strategies and guidance based on U.S. and international requirements

• Contribute to preparation of standard operating procedures for the regulatory department
• Perform other duties as assigned

Education and Experience

• A minimum of 5 plus years of experience within the regulatory environment
• BS or advanced degree in physical or life sciences preferred
• Proficient in Word, Excel, PowerPoint, SharePoint, and Adobe PDF; familiarity with Veeva a plus
• Performs in an effective/productive manner with minimal supervision
• Basic knowledge of global electronic submission regulations
• Detail-oriented with strong written and verbal communication skills
• Ability to multitask and prioritize when working on multiple projects, and deliver on tight timelines within a fast-paced team environment

Essential Skills and Abilities

• Unquestionable integrity, being 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
• Knowledge of FDA regulations
• Knowledge of foreign regulations and ICH
• Understanding of clinical operations and drug development
• Experience in the preparation and submission of INDs, CTAs, and amendments
• Able to review routine regulatory and scientific submission documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies
• Ability to prioritize multiple tasks

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.