Senior Director, Regulatory Affairs CMC

Full-TimeQEDAny Office LocationRegulatory Affairs

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QED Therapeutics, a subsidiary of BridgeBio Services, focuses on precision medicine for FGFR-driven cancers and diseases. The company’s first therapy, TRUSELTIQTM (infigratinib), is an orally administered FGFR1-3 tyrosine kinase inhibitor that the US FDA recently approved to treat patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement. We are also evaluating infigratinib for the treatment of other FGFR-driven cancers and the treatment of achondroplasia and other skeletal dysplasias. 

QED is derived from the Latin “Quod Erat Demonstrandum” —Thus; It Has Been Proven. Our business is inspired by our values:

PUT PATIENTS FIRST
LET SCIENCE SPEAK
EVERY MINUTE COUNTS
THINK INDEPENDENTLY
BE RADICALLY TRANSPARENT

FGFR=fibroblast growth factor receptor.

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  https://www.qedtx.com/ | https://bridgebio.com 

Who You Are:

The Senior Director of CMC Regulatory Affairs will establish the CMC regulatory submission development plan and lead the program's execution for drug substances and drug products from pre-clinical to eventual commercial development.
Responsibilities:
  • Establish, manage, and lead the CMC regulatory submission development program for drug substances and drug products, leading to submissions to health authorities. Prepare CMC documents for regulatory compliance
  • Work with project management to develop timelines and responsibilities for product development leading to submissions to health authorities
  • Key point of contact for CMC regulatory interactions with health authorities
  • Identify and support the selection of regulatory/CMC contractors/sites required to facilitate the development of regulatory filings related to CMC activities
  • Provide regulatory input to contract manufacturing, testing, packaging, and labeling operations. Guide external operations through tech transfer, process and method development, optimization, qualification, and validation of the activities related to the regulatory aspects of all manufacturing operations
  • Participate in product development project teams as CMC functional area representative
  • Work with Quality Assurance to develop SOPs and guidelines related to production, planning, and management, as required
Education, Experience & Skills Requirements:
  • BS/MS degree in a relevant discipline
  • A minimum of 10 years relevant experience in CMC project management development, scale-up and clinical development, and manufacturing in the biotechnology or pharmaceutical industry
  • Experience in process development and manufacturing
  • Experience in achieving regulatory approval of new drugs or biologicals
  • Strong verbal and written communication skills, interpersonal skills, ability to work well within a team, attention to detail, analytical and assessment skills, judgment, and problem-solving 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.
careers

Senior Director, Regulatory Affairs CMC

Full-TimeQEDAny Office LocationRegulatory Affairs

Apply Now