Manager/Senior Manager, Regulatory Affairs
Eidos Therapeutics, Inc.
Manager/Senior Manager, Regulatory Affairs
Who We Are:
A subsidiary of BridgeBio, Eidos Therapeutics 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.
Founded in 2013, Eidos is led by a team of industry veterans who are responsible for developing over 30 molecules through IND applications and more than 10 approved drugs. Together with patients and physicians, we aim to bring a safe, effective and disease-modifying treatment for ATTR to market as quickly as possible.
Our business is inspired by our values.
- PUT PATIENTS FIRST
- LET SCIENCE SPEAK
- ACT NIMBLY
- THINK INDEPENDENTLY
- BE RADICALLY TRANSPARENT
Who You Are:
Someone that thrives in a rapidly changing ambiguous environment. Embraces change, continuous learning and approaches each day with an improvement focused mindset.
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 the ability to apply their knowledge to daily work while managing critical projects as part of an interdisciplinary team.
The primary responsibilities for this position include planning, coordination, review and assembly of regulatory documentation for submission to health authorities (eg, FDA and global regulatory agencies). The primary job functions include, but not limited to the following:
- 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.) prior to submission.
- Coordinate with vendors to appropriately plan and finalize submissions to health authorities in accordance with regulations and guidelines.
- Contribute to 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 applicable US and global regulations, guidance, and standards for drug development and product registration.
Qualifications / Requirements:
- A minimum of a Bachelors Degree required (life sciences disciplines strongly preferred) with approximately 5 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).
- High 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.
- Understanding of the drug development process, FDA/EMA guidance and regulations, and knowledge of global guidance.
- Demonstrates creative approach to problem solving; with a demonstrated track record of being results driven.
- eg, 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 desirable.
- Experience in management of all components of regulatory submissions (including chemistry, manufacturing and controls) is a plus.
Special Skills / Knowledge:
- 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, Power Point, and document management software/system.
If you are interested in joining the Eidos team, please apply here.