Director, Regulatory Affairs

ML Bio Solutions Remote - United States Regulatory Affairs

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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 Director for ML Biosolutions Regulatory Affairs will be a strategic thinker with substantive experience with rare diseases and US/EU filings. This role requires an individual with high-quality standards to lead and execute the strategy for marketing application filings. This position is a US Lead Strategist role and will be part of a high-performing regulatory team. The individual for this role must have collaborative skills to allow for successful cross-functional interactions within the ML Biosolutions organization.

Responsibilities

  • Provide guidance and support to regulatory affairs’ team members and cross-functional teams
  • Advise and assist cross-functional teams on regulatory strategies to optimize and expedite the development and maximize the probability of success
  • Proactively identify program issues and implement appropriate regulatory strategies to mitigate risks
  • Develop, maintain, and communicate timelines for regulatory submissions to ensure timely delivery of regulatory documentation
  • Initiate and maintain regulatory applications to ensure compliance with regulations, including the preparation, review, and execution of pre- and post-marketing submission deliverables
  • 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.)
  • Function as Regulatory lead or co-lead on assigned project teams, providing regulatory guidance and recommendations that are in line with the company goals, international laws, and regulations, including but not limited to:
  • Lead or Co-lead for the execution of pre-and post-NDA activities
  • Lead or Co-lead for post-marketing pharmacovigilance regulatory activities may include registries, alerts, SDEAs, REMS, etc.
  • Lead and/or support strategy and execution of amendments/supplements as assigned
  • Interface with global regulatory authorities as needed
  • Assist with regulatory business development efforts as needed
  • When applicable, mentor and direct junior level regulatory personnel, who may or may not report directly to the incumbent
  • Manage other regulatory activities as assigned

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 7 years of relevant regulatory affairs experience with an advanced degree or 12 years with a Bachelor’s degree, with proven strategic involvement with small molecule drugs and/or biologics development is required
  • Rare Disease experience required; late-stage development for rare diseases is highly desirable
  • Experience with a successful US NDA submission experience in rare disease
  • Ability to analyze and interpret scientific data and regulations to apply to a rare disease program
  • Ability to communicate regulatory expectations that pertain to the drug development process, FDA/EMA/global guidance and regulations, to cross-functional teams
  • Evidence of being a critical strategic thinker who is solution-oriented with the ability to think outside of the box; preference for demonstration of such within rare disease programs
  • 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 knowledge of global operational regulations and guidelines
  • Excellent written and oral communication skills
  • Demonstrated influencing and leadership skills

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
At 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.
Salary
$215,000$265,000 USD

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Director, Regulatory Affairs

ML Bio Solutions Remote - United States Regulatory Affairs

Apply Now