Associate Director, CMC Regulatory Affairs

Origin Biosciences, a subsidiary of BridgeBio Pharma, is a biotechnology company focused on developing and commercializing a treatment for Molybdenum Cofactor Deficiency (MoCD) Type A. Origin is led by a team of veteran biotechnology executives. Together with patients and physicians, the company aims to bring a safe, effective treatment for MoCD Type A to market as quickly as possible.

With singular focus, QED is devoted to the development of our investigational candidate, infigratinib. A first-in-class, selective, tyrosine kinase inhibitor, infigratinib has promising early clinical data in patients with previously treated, FGFR-driven cholangiocarcinoma and metastatic urothelial carcinoma, as well as preclinical studies in achondroplasia. Future studies will investigate infigratinib for additional FGFR-driven tumor types and rare disorders. FGFR=fibroblast growth factor receptor.

BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas, including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company's focus on scientific excellence and rapid execution aim to translate today's discoveries into tomorrow's medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh with small satellites in other parts of the country.

To learn more, visit: qedtx.com | origintx.com | www.bridgebio.com

Who You Are:

The Associate Director, Regulatory Affairs (RA) will be a strategic thinker with substantive experience with rare diseases and marketing applications filings. This role requires an individual with a high-quality standard that can lead and execute developed strategy for marketing application filings. This position requires CMC regulatory leadership to achieve regulatory approvals. As a strategic function, CMC RA collaborates closely with multiple scientific, technical, quality, and commercial areas within a company or with external contract manufacturing organizations (CMOs). This position will be part of two high-performing regulatory teams. The individual for this role will have collaborative skills to allow for successful cross-functional interactions.

Responsibilities:

• Understands, interprets and advises on regulations, guidelines, and procedures relating to development, registration, and manufacturing of drug products, with the goal of expedite submission, review, and approval of CMC applications
• Assess data with technical functional expertise to solve problems and make good decisions for the overall business
• Represent RA on Technical Operations teams and provide strategic direction and guidance to colleagues and CMO team members to support successful development of assets; ultimately being accountable for regulatory strategies, plans, and activities
• Prepares and manages CMC RA content for submissions, ensuring high quality and timely submissions. Submissions may include:
• MAAs/NDAs - Module 3 and QOS content, supplemental submissions, and responses to health authority questions in support of drug product development, commercialization, and lifecycle management;
• IND and other clinical trial applications in support of drug product product development
• Delivers CMC regulatory strategy to support major inspections (e.g.: PAI's), change controls, or quality incidents
• Additional responsibilities may include API development and validation, drug product development, validation and commercialization, design control strategy and documentation, and Human Factors validation testing
• Identify risks to the business associated with submission data and information packages and provide and communicate well defined risk‑mitigation strategies
• Formulates novel approaches and influences people, systems, and processes

Preferred Qualifications:

• BS degree required; Advanced degree (MS, PhD) in Chemistry, Biology, or related field encouraged
• Minimum of 10 years experience in CMC Regulatory Affairs or related experience in positions of increasing responsibility, preferably with pre- and post-marketing development experience
• Additional knowledge of device development is a plus
• Rare Disease experience required; late stage development for rare diseases is preferable
• Successful MAA and NDA submission experience
• Ability to analyze and interpret scientific data and regulations to apply to a rare disease program
• Experienced in Regulatory Agency meetings resulting in successful outcomes
• Knowledge and practical understanding of ICH and EMA Guidelines regarding GMP/GCP and CTD/eCTD, and US FDA CDER requirements for the drug approval process
• Ability to prioritize multiple urgent priorities and experience with wearing multiple hats
• Thorough understanding and demonstrated experience with eCTD submission requirements, utilizing document templates, and knowledgeable of global operational regulations and guidelines
• Excellent written and oral communication skills and experience with communicating vertically and horizontally within an organization
• Demonstrated influencing and leadership skills, while respectful and collaborative team player
• Fluent with Microsoft Office (Word, Excel, Powerpoint) and Adobe Acrobat (PDF) rendering software

What We Offer:

• Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts
• A culture inspired by our values: put patients first; think independently, be radically transparent; every minute counts, and let the science speak
• Learning and development training to help employees be the best version of themselves
• Collaborative business environment
• Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
• Excellent benefits package
• Flexible PTO
• With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
• A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
• Work with the most productive groups of R&D operators in the industry
• Partnerships with leading institutions
• A platform for meaningful scientific contributions to shine
• Commitment to Diversity & Inclusion - with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so