Jobs

Sr Director, Regulatory Affairs

About Sonoma Biotherapeutics

Sonoma Biotherapeutics is a South San Francisco and Seattle-based company leading the development of adoptive Treg therapies cell for autoimmune and degenerative diseases. Using next-generation genome editing and target-specific cell therapy, Sonoma is focused on developing its best-in-class platform across the entire spectrum of Treg cell therapeutic capabilities. Founded by pioneers in Treg biology and cell therapy, the company brings together leading expertise and proprietary methodologies for the discovery and development of disease modifying and curative therapies. More information at www.sonomabio.com.

Job Purpose/Summary:

Sr Director, Regulatory Affairs will lead and oversee the global regulatory process for multiple therapeutic programs. The Sr Director will be responsible for contributing to overall regulatory strategy, regulatory risk assessment, and regulatory interactions. This role is both strategic and operational, requiring the ability to own and drive regulatory strategy and execution for the company’s development programs. Reporting to the Vice President, Regulatory Affairs, the Sr Director will partner with internal and external stakeholders to ensure quality and timely global regulatory submissions and approvals.

This position will be based on-site or hybrid in South San Francisco, CA. or Seattle, WA.  Especially strong candidates may be considered for remote opportunities.

Roles and responsibilities:

• Provide regulatory guidance, direction, and leadership on those strategies to the development teams
• Make strategic contributions to the development and implementation of product development plans and partner with Program Teams (including Development Sciences, Translational Medicine, Clinical Sciences/Operations, and CMC) to set up and achieve the development objectives
• Prepare, review, or sign-off key regulatory meeting requests and briefing documents and lead the preparation and interactions with regulatory authorities
• Manage the preparation of all global regulatory submissions (from INDs to marketing applications) to the FDA, EMA, PMDA, and other global regulatory agencies, including cell therapy products and companion diagnostic tests
• Manage on-going regulatory submission and reporting requirements
• Provide innovative approaches to resolve complex regulatory issues and increase speed to patients
• Maintain up-to-date working knowledge of US laws, regulations, and guidelines as well as familiarity with the global regulatory environment and share the updates with relevant functions and colleagues
• Represent the regulatory function on cross-functional Program team(s) and senior management meetings.
• Establish, update, and implement regulatory policies, standards, and procedures for the company for quality and compliance
• Partner with Quality and Clinical Operations to ensure operations are compliant with FDA, ICH, EMA, and industry standards.
• Manage the regulatory aspects of products and projects including achievement of timelines and deliverables
• Identify, engage, and manage network of regulatory experts and consultants

Qualifications and Education Requirements:

• Bachelor’s degree in life sciences; advanced degree desirable
• 12+ years’ biopharmaceutical experience, including at least 8 years of direct experience in Regulatory Affairs
• Track record of successful IND/CTA, NDA, and/or BLA submissions and approvals
• Extensive knowledge of clinical development, regulations of FDA, EMA, and PMDA and international global clinical trial regulations
• Proven leadership to build and lead regulatory affairs teams
• Knowledge of GxP regulations and ICH and FDA guidelines
• Experience in global submissions and approvals in Europe and Asian-Pacific
• Ability to blend analytical and critical thinking skills to enable data-driven, strategically oriented review of regulatory documents
• Demonstrated communication, analytic, problem-solving, organizational, and negotiation/decision-making skills
• Nimble, creative, entrepreneurial with the ability to independently execute
• Track record to collaborate with and mentor talents
• Demonstrated ability to work in an innovative and fast-paced environment
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders

Preferred Skills:

• Experience in cell therapy research and development
• Experience in a start-up environment
• Regulatory Affairs Certification (RAC) or education in a regulatory field

A day in the life:

In any start-up, a day in the life may vary. However, the Sr Director, Regulatory Affairs will work cross-functionally with Sonoma Bio leadership, partnering with Quality and Clinical Operations, to create the best practices and set up all appropriate protocols, policies and processes that support Sonoma Bio’s growing portfolio/pipeline.

Learn more here

Job posted: 2023-05-07