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 aims 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 ML Bio Solutions | BridgeBio 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.
ResponsibilitiesEnsure 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 timelinesMaintain all regulatory applications to ensure compliance with regulations, including the preparation, review, and execution of pre- and post-marketing submission activitiesAssist the regulatory team by leading and advising cross-functional teams on assigned projects with regulatory strategies to help optimize and expedite product developmentAssist 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 deliverablesAssist 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 meetingsDevelop, maintain, and communicate timelines for regulatory submissions to ensure timely delivery of regulatory documentationManage 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 lawsParticipate 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 senior management and cross-functional teamsWork with regulatory affairs leadership to review and approve promotional and non-promotional materials as requiredAssist with all regulatory business development efforts as neededNo matter your role at BridgeBio, successful team members are: Patient Champions, who put patients first and uphold strict ethical standardsEntrepreneurial Operators, who drive toward practical solutions and have an ownership mindsetTruth Seekers, who are detailed, rational, and humble problem solversIndividuals Who Inspire Excellence in themselves and those around themHigh-quality executors, who execute against goals and milestones with quality, precision, and speedEducation, Experience & Skills RequirementsAdvanced degree (M.S., Pharm.D., Ph.D.) or B.S. Degree in Biology, Immunology, or related fieldMinimum 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 requiredRare disease experience is preferable; experience with late-stage development work is highly desirableAbility to analyze and interpret scientific data and regulations to apply to a drug development programEvidence of being a critical strategic thinker who is solution-oriented with the ability to think outside of the boxExcellent written and oral communication skillsFluent with Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat (PDF) rendering softwareWhat We OfferPatient 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 effortsA culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speakA 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 scienceA place where you own the vision – both for your program and your own career pathA collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our gameAccess to learning and development resources to help you get in the best professional shape of your lifeRobust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)Flexible PTORapid career advancement for strong performersPotential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over timeCommitment to Diversity, Equity & InclusionAt BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
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