Associate Director, Regulatory Affairs

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement…read on

In 2015, we pioneered a “Moneyball for biotech” approach, pooling projects and promising early-stage research from academia under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare diseases and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 

Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

Affiliate Overview

QED Therapeutics, an affiliate within 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.

What You’ll Do

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

Responsibilities

• Develop and execute regional regulatory strategies in support of development programs. Provide regional regulatory guidance and strategy for support of product development and registration strategies, including broad regulatory oversight for nonclinical/clinical development  
• Represent Regulatory at cross-functional team meetings
• Lead study-related regulatory activities: 
  • Act as the regulatory study representative at cross-functional team meetings 
  • Provide strategic regulatory guidance internally on study-level decision-making 
  • Keep study team informed of regulatory activities in the context of study team management meetings 
  • Provide ownership of study-level global regulatory activities, including clinical trial application (CTA) and IND submissions, review and approval of investigator document packages and associated FDA submissions, and manage other regulatory aspects of the study as necessary
  • Manage tracking of regulatory/ethics submissions and approvals across all studies 
• Facilitate FDA or other Health Authority meetings in collaboration with Regulatory leadership
• Collaborate with Project Team representatives in the planning of regulatory documents; support processes by which regulatory submissions are reviewed, finalized, and signed-off
• Manage and track queries and commitments with regulatory agencies, collaborate with subject matter experts to provide written responses, and provide periodic status updates regarding unfulfilled conditions/commitments 
• Input to global regulatory submissions and strategic planning as applicable 

Where You’ll Work

• This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco, CA office

Who You Are

• BA/BS degree in the biological or physical sciences.  Advanced degree preferred 
• Relevant pharmaceutical industry experience, including experience in regulatory affairs; a minimum of 5 years of industry experience is generally required 
• Knowledgeable of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry-standard practices 
• Proficient in written, oral, and interpersonal communication in English 
• Ability to work in close collaboration with colleagues in the regulatory department and throughout the development organization 
• Capability to provide strategic guidance on regulatory and program-related issues 
• Ability to problem solve unexpected problems or roadblocks that arise  
• 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 

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work 
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability 
• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities