Sr. Director, Reg 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 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.

What You'll Do

#LI-TC1 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.

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 Where You'll Work This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco and Palo Alto Office.

Who You Are

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 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 #LI-TC1 At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits.

Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process.

BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary$270,000—$320,000 USD

BridgeBio Pharma (NASDAQ: BBIO) is a biopharmaceutical company dedicated to advancing a diverse pipeline of medicines that target genetic diseases. Founded in 2015, BridgeBio is committed to developing innovative therapies that address unmet medical needs in various rare and genetic diseases. With a focus on precision medicine and a patient-centered approach, BridgeBio is at the forefront of revolutionizing treatment options for individuals affected by genetic disorders.