Associate Director / Director, Regulatory Affairs

Location
Palo Alto, CA, United States
Posted
Nov 19, 2020
Ref
720602026
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Calcilytix Therapeutics, a subsidiary of BridgeBio Pharma, is a clinical stage biopharmaceutical company focused on addressing disorders of calcium homeostasis at the source. Our product candidate is an orally-administered small molecule that specifically inhibits the calcium sensing receptor, hypothesized to restore normal serum calcium and lower urine calcium.

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.

To learn more, visit us at https://bridgebio.com

Location:

San Francisco, CA

Who you are:

This experienced regulatory professional will have demonstrated the ability to work independently or with limited direction and oversight. The individual will manage internal regulatory processes, prepare documents for regulatory submissions in compliance with global health authority regulations, and may interact with health authorities. In conjunction with regulatory affairs leadership, they will develop strong relationships, collaborate, and interact with various departments and levels of management, including interactions across BridgeBio subsidiaries. Furthermore, the successful candidate will have demonstrated knowledge of regulatory requirements and guidelines and the ability to apply their knowledge to daily work and be capable of representing regulatory affairs as part of an interdisciplinary team.

Responsibilities:
  • Planning, coordination, review and assembly of regulatory documentation for submission to health authorities (eg, FDA and global regulatory agencies)
  • Independently or with limited oversight plan, compile, review, and submit documents for the company, including but not limited to initial INDs/CTAs/NDAs/MAAs and amendments or supplements
  • Provide regulatory direction to 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.
  • Maintain regulatory databases, including submission 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

Preferred Qualifications:
  • A minimum of a Bachelors Degree required (life sciences disciplines strongly preferred) with approximately 7 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 leading eCTD formatted submissions, e.g. INDs, NDAs/BLAs, MAAs, annual reports, amendments and supplements, for drugs and/or biologics
  • Has successfully led responses to health authorities or other critical submission while maintaining agreed timelines
  • Ability to communicate regulatory expectations that pertain to of the drug development process, FDA/EMA/global guidance and regulations, to cross-functional teams
  • Excellent oral and written communication 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 with strong attention to detail to meet company objectives
  • Knowledge of ICH, GCP, GMP, and other relevant global guidelines
  • Excellent computer skills, eg MS Word, Excel, Power Point, and electronic document management software/systems

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