Manager/Senior Manager, Regulatory Affairs

Full-TimeEidosSan Francisco, CARegulatory Affairs

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Eidos Therapeutics, a subsidiary of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our product candidate, AG10, is an orally-administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

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 aims to translate today’s discoveries into tomorrow’s medicines. We have offices in the US (San Francisco, Palo Alto, Boston, New York, Raleigh), and EMEA (Zug, Switzerland) with small satellites in other parts of the country. 

To learn more, visit us at  eidostx.com/ www.bridgebio.com

Who You Are:

The candidate will have demonstrated the ability to work independently or with limited oversight. Furthermore, the candidate will have demonstrated knowledge of regulatory requirements and guidelines and apply their knowledge to daily work while managing critical projects as part of an interdisciplinary team.
Responsibilities:
  • Independently or with limited oversight plan, compile, review, and submit documents for the company, including but not limited to initial INDs/CTAs/NDAs and amendments or supplements
  • Assist regulatory management and project teams in the development and implementation of regulatory strategies and plans
  • Develop, maintain, and communicate timelines for regulatory submissions to ensure timely delivery of regulatory documentation
  • Participate in the review of critical documents such as protocols, ICFs, IBs, CSRs, DSURs, etc., to ensure they are compliant with relevant regulations and guidance (e.g., ICH, FDA, EMA, etc.) before submission
  • Coordinate with vendors to appropriately plan and finalize submissions to health authorities per regulations and guidelines
  • Contribute to the maintenance of regulatory databases, including submissions and correspondence logs
  • Independently plan daily work to complete time-sensitive assignments
  • Review, write, and present guidelines and SOPs as needed to support high-quality submissions and assure adherence to regulatory requirements
  • Maintain current knowledge of the applicable US and global regulations, guidance, and standards for drug development and product registration
Education, Experience & Skills Requirements:
  • A minimum of a Bachelors Degree required (life sciences disciplines strongly preferred) with approximately five years of experience in the biotechnology or pharmaceutical industries in regulatory affairs or related functions in drug/biologics development/manufacturing (an equivalent combination of education and experience may be considered)
  • Great attention to detail, ability to work on multiple projects with tight deadlines, and able to work independently
  • Demonstrated experience working to support eCTD formatted submissions for drugs and/or, e.g., INDs, NDAs/BLAs, MAAs, annual reports, amendments, and supplements
  • e.g., Has successfully coordinated or supported responses to health authorities or other critical submission projects while maintaining agreed timelines
  • Previous experience with NDA or BLA submissions is desirable
  • Experience in managing all components of regulatory submissions (including chemistry, manufacturing, and controls) is a plus
  • Understanding of the drug development process, FDA/EMA guidance and regulations, and knowledge of global guidance
  • Demonstrate a creative approach to problem-solving; with a demonstrated track record of being results-driven
  • Excellent oral and written communication skills and time management skills essential
  • Demonstrated ability to work effectively with and/or lead cross-functional team activities e.g., research, clinical, and CMC teams
  • Ability to develop regulatory plans and strategies while proactively identifying risks
  • Ability to work on multiple tasks to meet company objectives
  • Strong attention to detail
  • Knowledge of 21 CFR and FDA, ICH, GCP, GMP, and global guidelines
  • Excellent Computer Skills – MS Word, Excel, PowerPoint, and document management software/system
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.
careers

Manager/Senior Manager, Regulatory Affairs

Full-TimeEidosSan Francisco, CARegulatory Affairs

Apply Now