Senior Director, Regulatory Affairs CMC

Location
Working from home
Posted
Oct 01, 2021
Required Education
Bachelors Degree
Position Type
Contract
About QED Therapeutics & BridgeBio Pharma

QED Therapeutics, an affiliate of BridgeBio Pharma, 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 is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, Boston, New York, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, 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
  • No matter your role at BridgeBio, successful team members are:

  • Patient Champions, who put patients first and uphold strict ethical standards
  • Entrepreneurial Operators, who drive towards practical solutions and have an ownership mindset
  • Truth Seekers, who are detailed, rational, and humble problem solvers
  • Individuals Who Inspire Excellence in themselves and those around them
  • High-quality executors, who execute against goals and milestones with quality, precision, and speed


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 to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn 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
  • An unyielding commitment to always putting patients first. Learn more about how we do this here
  • A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
  • A place where you own the vision – both for your program and your own career path
  • A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
  • Access to learning and development resources to help you get in the best professional shape of your life
  • Robust and market competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
  • Flexible PTO
  • Rapid career advancement for strong performers
  • Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
  • Partnerships with leading institutions
  • Commitment to Diversity, Equity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels seen, valued, and heard


We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.