Manager/Senior Manager, Regulatory Affairs

Location
Boston, MA
Posted
Jul 20, 2021
Required Education
Bachelors Degree
Position Type
Full time
Who You Are:

We are looking for a talented and motivated regulatory affairs leader to help develop and execute global regulatory strategies aimed at the most efficient regulatory pathway for oncology drug and/or diagnostic development programs. This involves collaboration with cross-functional project teams in planning development strategies and leading global regulatory submissions for assigned projects.

Reporting to a Director of Regulatory Affairs, the Manager will support day-to-day regulatory activities of assigned oncology projects.  These include support of preparation, compilation, and execution of submissions for regulatory agencies, assigned clinical studies, management of regulatory submission processes and timelines, and regulatory tracking tools, archives, and infrastructure, as assigned. This position will support two BridgeBio subsidiaries: QED Therapeutics and Navire Pharma (50%/50% split).

About Us:

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 for the treatment of 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 as well as for 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.

Navire Pharma, another subsidiary of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on harnessing breakthrough discoveries in our understanding of SHP2 to address the large and growing unmet need in rare and difficult-to-treat cancers. Navire’s team of veteran biotechnology executives are partnering with leading cancer experts to advance effective therapies to patients as rapidly as possible.

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://navirepharma.com | https://bridgebio.com 

Responsibilities:
  • As the regulatory representative for assigned clinical studies, you will:
  • Provide ownership of study-level regulatory activities, including clinical trial application (CTA) and IND submissions, review and approval of investigator document packages and associated FDA submissions, and manages other regulatory aspects of the study as necessary
  • Act as the regulatory study representative at cross-functional team meetings
  • Provides regulatory guidance internally on study-level decision-making
  • Keeps study team informed of regulatory activities in the context of study team management meetings
  • Manage and track queries and commitments with regulatory agencies, collaborate with subject matter experts to provide written responses to queries, provide periodic status updates regarding unfulfilled conditions/commitments
  • Collaborate with Project Team representatives in the planning of regulatory documents, including responses to Health Authority queries; support processes by which regulatory submissions are reviewed, finalized, and signed-off
  • Manage the tracking of regulatory/ethics submissions and approvals across all studies
  • Manage document archive processes
  • Support global regulatory submissions and strategic planning as applicable


Education, Experience & Skills Requirements:
  • BA/BS degree in the biological or physical sciences preferred
  • Three years minimum industry experience is generally required in the relevant pharmaceutical industry, including regulatory affairs
  • Knowledgeable of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry-standard practices
  • Proficient in written, oral, and interpersonal communications in English
  • Ability to work in close collaboration with colleagues in the regulatory department and throughout the development organization
  • High attention to detail; ability to organize, prioritize, and delegate assigned projects
  • Experience interacting with CROs in the management of US eCTD IND submissions and ex-US CTAs towards clinical trial activations preferred
  • Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems and document review tools desirable


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.