Director/Sr. Director, Regulatory Affairs

About QED Therapeutics & BridgeBio Pharma

QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families.
 
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, Raleigh, and 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

As the Director/Sr. Director, Regulatory Affairs, you are a driven global regulatory leader with expertise in regulatory strategy development and execution. You excel at navigating global health authority interactions, leading cross-functional teams, and driving clinical and licensing submissions.

Reporting to the QED Head of Regulatory Affairs, you will provide leadership in regulatory activities for assigned programs, including developing global regulatory strategies, leading submissions, and managing critical health authority interactions.

Responsibilities

• Provide leadership in creating and executing proactive regulatory strategies for product development, approval, and registration
• Apply knowledge of global quality/regulatory standards and guidelines to ensure requirements are met across programs
• Partner with internal senior leadership to align closely on cross-functional global regulatory plans and the company's short and long-term strategic objectives
• Take complete ownership of relevant regulatory submission deliverables
• Represent regulatory in senior management discussions and present strategies, recommendations, and risks accordingly
• Lead the specific Affiliate regulatory strategy team by managing, mentoring, and teaching capabilities
• Work at both high-level strategic and hands-on in leading an agile team
• Serve as a key regulatory team member with responsibility for regulatory strategies and submissions, lead asset
• Provide regulatory guidance and strategy for support of product development and registration strategies
• Ensure high-quality and timely regulatory submissions (IND/CTA/NDA/MAA/IDE/PMA, as applicable) in compliance with all applicable regulatory requirements and in alignment with corporate goals
• Provide leadership and oversight of the preparation of all critical global regulatory submissions (from pre-IND to post-marketing) to the FDA, EMA, and other international health authorities
• Act as the primary liaison with regulatory authorities
• Direct and assist internal staff and regulatory consultants, as required, to ensure compliance of drug development activities with all U.S. and international requirements
• Analyze and communicate current regulatory guidance and regulations, as well as industry and regulatory agency best practices and trends, to keep the company informed on any relevant changes in the regulatory landscape
• Support due diligence and partnering activities as needed
• Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations

No matter your role at BridgeBio, successful team members are:

• Patient Champions, who put patients first and uphold strict et