Manager/Sr. Manager, Regulatory Affairs

About MLBio Solutions & BridgeBio Pharma

ML Bio Solutions (ML Bio), a BridgeBio company, is a biotechnology company founded in 2018, yet the company’s founders have been dedicated to finding a cure for Limb girdle muscular dystrophy type 2I/R9 FKRP-related (LGMD2I/LGMDR9) for close to twenty years. ML Bio is developing BBP-418, potentially the first oral treatment for patients with LGMD2I.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas, including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.  
 
Our focus on scientific excellence and rapid execution aim to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe. 
 
To learn more about our story and company culture, visit us at https://mlbiosolutions.com/ | https://bridgebio.com

Who You Are

The Manager/Sr. Manager, Regulatory Affairs will be a strategic thinker and responsible for overseeing (with support) the regulatory assessment and research on regulatory precedence to evaluate regulatory strategies for development programs focused on rare diseases. As assigned, this individual will also be responsible for application maintenance activities, amendments/supplements, and other policies and procedures. This position is a generalist role and will be part of a high-performing regulatory team working across the neurology space within ML Bio/BridgeBio. The individual for this role will have collaborative and leadership skills to allow for successful cross-functional interactions within the ML Bio organization.

Responsibilities

• Ensure effective timeline management for preparing and reviewing submissions and applications, including ODAs, BTD, CTAs, INDs, NDAs, BLAs, MAAs and all equivalent submissions globally within the established timelines
• Maintain all regulatory applications to ensure compliance with regulations, including the preparation, review, and execution of pre- and post-marketing submission activities
• Assist the regulatory team by leading and advising cross-functional teams on assigned projects with regulatory strategies to help optimize and expedite product development
• Assist in the Initiation and maintenance of regulatory applications to ensure compliance with regulations, including the preparation, review, and execution of pre- and post-marketing submission deliverables
• Assist in the management of communications with regulators (globally) as assigned, including submission of informal and formal correspondences, responses to Agency requests for information, and pre-meeting packages; participate in the preparation and conduct of Agency meetings
• Develop, maintain, and communicate timelines for regulatory submissions to ensure timely delivery of regulatory documentation
• Manage coordination with Reg Operations Team (publishers) for assigned submissions to Agencies to ensure proper direction, preparation, and quality Q.C. is performed, and all submissions are timely and in compliance with all Agency laws
• Participate in the review of critical documents such as protocols, ICFs, IBs, CSRs, DSURs, etc., to ensure compliance with relevant regulations and guidance (e.g., ICH, FDA, EMA, etc.)
• Conduct Regulatory Intelligence related to the assigned programs and disseminate relevant information to Sr. Management and cross-functional teams
• Work with Regulatory Affairs leadership to review and approve promotional and non-promotional materials as required
• Assist with all regulatory business development efforts as needed

No matter your role at BridgeBio, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors, who execute against goals and milestones with quality, precision, and speed

Education, Experience & Skills Requirements

• Advanced degree (M.S., Pharm.D., Ph.D.) or B.S. Degree in Biology, Immunology, or related field
• Minimum of 2 years of relevant regulatory affairs experience with an advanced degree or 5 years with a Bachelor’s degree, with proven strategic involvement with small molecule drugs and/or biologics development is required
• Rare Disease experience is preferable; experience with late-stage development work is highly desirable
• Ability to analyze and interpret scientific data and regulations to apply to a drug development program
• Evidence of being a critical strategic thinker who is solution-oriented with the ability to think outside of the box
• Excellent written and oral communication skills
• Fluent with Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat (PDF) rendering software

What We Offer

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn 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
• An unyielding commitment to always putting patients first. Learn more about how we do this here
• A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• A place where you own the vision – both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time 
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion