Sr. Director, Reg Affairs

BridgeBio Pharma•San Francisco, CA

11d•Hybrid

About The Position

In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together 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 disease, 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. As the Senior Director, Regulatory Affairs, you are a driven global regulatory leader with expertise in regulatory strategy development and execution. You excel in 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 as well as leading regulatory staff.

Requirements

Bachelor's degree in the scientific field is required; an advanced degree (MD, Ph.D., PharmD, MS) preferred
A minimum of 15 years of relevant pharmaceutical/biotechnology regulatory affairs experience in the pharmaceutical industry, including expertise leading a Regulatory Affairs group
Well-versed in the drug development process and regulatory requirements, as well as a good understanding of the underlying science
Strong attention to detail
Excellent written and verbal communication skills
Excellent project management skills, with the ability to manage multiple projects and prioritize appropriately
Ability to rapidly understand & analyze complex problems/situations
Ability to lead teams under tight timelines and be willing to contribute significantly to day-to-day operations as needed
Comfort in a team environment
Strong interpersonal skills and the ability to effectively work with others
Ability to influence without authority, lead change
Ability to solicit information, persuade others, and shape outcomes
Experience working with all levels of management and consulting with key business stakeholders (internal and external)
Travel to key meetings and Health Authority interactions as needed

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 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 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

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
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
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