Director/Senior Director, Regulatory Affairs CMC

Location
San Francisco, California
Posted
Jun 08, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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 San Francisco, Palo Alto, Boston, New York, and Raleigh with small satellites in other parts of the country. 

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

Who You Are:

This experienced Regulatory Affairs team member will provide CMC regulatory expertise and support for development project work, including CMC regulatory support to primary authors and review of related regulatory submissions. This individual will represent CMC Regulatory Affairs on CMC and Regulatory Submission Teams and ensure the planning, development, and finalization of high-quality CMC documentation designed to meet regulatory requirements while overseeing registration submissions.

This individual is the responsible subject-matter expert in the field of Regulatory CMC with experience filing a successful NDA/MAA for a new chemical entity and will function as an individual contributor and have a direct influence on the decision-making processes within the scope of CMC related activities at Eidos and across BridgeBio affiliates as needed.

This successful individual is expected to develop strong relationships with various departments and different management levels, including interactions across BridgeBio affiliates. The scope of this role ranges from early clinical development through submission and maintenance of license applications.

Responsibilities:
  • Work closely with CMC and Quality colleagues to develop CMC regulatory submission strategies, complete content review, assure compliance with regulatory standards and health authority guidance while maintaining submission timelines to meet business objectives
  • Ensure communication and alignment on CMC regulatory strategy through partnership and communication with internal key stakeholders
  • Proactively identify potential risks to programs and contribute to solutions to keep assigned programs on track while maintaining high quality
  • Plan and track the completion of CMC content for NDA/MAA and IND/CTA submissions while ensuring company template content conforms with regulatory requirements
  • Coordinate responses to CMC information requests from health authorities
  • Ensure that CMC-related changes are reported to authorities per regulatory requirements
  • Lead preparation for health authority meetings with CMC focus and participate in multidisciplinary efforts to prepare CMC updates to regulatory documents including, Investigator Brochures, Annual Reports, and briefing documents for health authority meetings
  • Maintain a centralized archive for monitoring status and effectively communicating regulatory CMC commitments and agency reporting obligations for the organization
  • Ensure that appropriate documented quality control (QC) checks are performed for CMC documents before health authority submission and respond to findings, and recommend process improvements as needed
  • Collaborate with CMC Team and Quality to ensure regulatory conformance of technical documentation, including technical transfer protocols, validation protocols, and technical reports, manufacturing and packaging/labeling information
  • Maintain knowledge of current and emerging CMC regulatory requirements, guidelines, and best practices, and effectively communicate relevant topics to colleagues
  • Oversee responsibilities for department staff and vendors as agreed with the manager
  • Support other Regulatory Affairs functions as needed


Education, Experience & Skills Requirements:
  • BA/BS degree in chemistry or similar required, post-graduate degree preferred
  • Successful experience leading Regulatory CMC activities for multiple regulatory filings in pre-and post-approval settings, including experience filing an NDA/MAA for an NCE
  • Excellent oral and written communication skills with proven ability to analyze and organize information logically
  • Thorough knowledge of drug development, health authority regulations and guidelines, CMC and Quality documentation standards, with the ability to apply knowledge to guide the delivery of regulatory documents efficiently
  • Strong leadership and project management skills, ability to work independently, multi-task, and work effectively under pressure
  • Excellent interpersonal, active listening, and influencing skills
  • Strong collaboration, teamwork, organizational skills, and attention to detail
  • Prior management experience preferred


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.