Manager / Sr. Manager, Regulatory Affairs Remote - United States

About MLBio Solutions & BridgeBio Pharma

ML Bio Solutions (ML Bio), a BridgeBio company , is a biotechnology company founded in 2018, dedicated to finding a cure for Limb girdle muscular dystrophy type 2I / R9 FKRP-related (LGMD2I / LGMDR9).

ML Bio is developing BBP-418, potentially the first oral treatment for patients with LGMD2I.

BridgeBio is a biopharmaceutical company focused on discovering, creating, testing, and delivering transformative medicines for genetic diseases and cancers.

We bridge the gap between advancements in genetic science and the delivery of meaningful medicines to patients. Founded in 2015, the company has a portfolio of 30+ drug development programs across various therapeutic areas, with two approved drugs.

Our focus on scientific excellence aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, and international offices in Montreal and Zurich.

To learn more about our story and company culture, visit us at ML Bio Solutions BridgeBio

The Manager / Sr. Manager, Regulatory Affairs will oversee the regulatory assessment and research on regulatory precedence to evaluate strategies for development programs focused on rare diseases.

This individual will also be responsible for application maintenance activities, amendments / supplements, and other policies and procedures, working within a high-performing regulatory team across the neurology space.

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.
• Maintain all regulatory applications to ensure compliance with regulations, including preparation, review, and execution of pre- and post-marketing submission activities.
• Lead and advise cross-functional teams on assigned projects with regulatory strategies to optimize product development.
• Manage communications with regulators globally, including informal and formal correspondences, responses to Agency requests for information, and pre-meeting packages.
• Develop, maintain, and communicate timelines for regulatory submissions to ensure timely delivery of documentation.
• Coordinate with Reg Operations Team for assigned submissions to ensure quality and compliance.
• Participate in the review of critical documents such as protocols, ICFs, IBs, CSRs, DSURs, etc.
• Conduct Regulatory Intelligence related to 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. 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.
• Rare Disease experience is preferable; experience with late-stage development work is highly desirable.
• Ability to analyze and interpret scientific data and regulations.
• Evidence of being a critical strategic thinker who is solution-oriented.
• Excellent written and oral communication skills.
• Proficient with Microsoft Office and Adobe Acrobat.

What We Offer

• Patient Days, where we hear directly from individuals living with the conditions we are seeking to impact.
• A culture inspired by our values : put patients first, think independently, be radically transparent, every minute counts, and let the science speak.
• A commitment to always putting patients first.
• A decentralized model that empowers program teams to focus on advancing science.
• A collaborative, fast-paced, data-driven environment.
• Access to learning and development resources.
• Robust and market-competitive compensation & benefits package.
• Flexible PTO.
• Rapid career advancement for strong performers.
• Commitment to Diversity, Equity & Inclusion.

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