Director, Regulatory Affairs

Working from home
Apr 10, 2021
Required Education
Position Type
Full time
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.

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.

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Who You Are:

The Director for Origin Regulatory Affairs will be a strategic thinker with substantive experience with rare diseases and European filings.  This role requires an individual with a high-quality standard to lead and execute a developed strategy for marketing application filings. This position is a generalist role and will be part of a high-performing regulatory team. The individual for this role will have collaborative skills to allow for successful cross-functional interactions within the Origin organization.

  • Provide guidance and support regulatory affairs’ team members and cross-functional teams and related activities
  • Advice and assist cross-functional teams of regulatory strategies that optimize and expedite the development and maximize the probability of success by mitigating anticipated risks
  • Maintain regulatory applications to ensure compliance with regulations, including the preparation, review, and execution of pre-and post-marketing submission deliverables
  • Regulatory lead or co-lead on assigned drug project teams, providing regulatory guidance and recommendations that are is in line with the company goals, international laws, and regulations, including but not limited to:
  • Lead or Co-lead for pre-and post-MAA activities
  • Lead or Co-lead for the execution of Global marketing applications
  • Lead or Co-lead for post-marketing labeling activities, which may include the maintenance of the global CCDS, the Labeling – Safety Committee, Labeling studies (e.g., human factor studies)
  • Regulatory lead for post-marketing pharmacovigilance regulatory activities may include registries, alerts, SDEAs, Riskmaps, etc.
  • Lead and/or support strategy and execution: amendments/supplements, and other policies and procedures as assigned
  • Assist with all 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, which may involve nonclinical studies and strategies, and commercial activities

Education, Experience & Skills Requirements:
  • Advanced degree (M.S., Ph.D.) or B.S. Degree in Biology, Immunology, or related field
  • Minimum of 13 years of regulatory affairs experience with proven strategic involvement with drug and/or biologic development is required; additional knowledge of device development is a plus
  • Rare Disease experience required; late-stage development for rare diseases is preferable
  • Experience with a successful EU submission experience in rare disease
  • Ability to analyze and interpret scientific data and regulations to apply to a rare disease program
  • 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; management also of non-regulatory functional activities is preferred
  • 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 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

We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.