Director/Sr. Director, Regulatory Affairs

BridgeBio; United States; Remote; USD 215,000 - 315,000; Full time

Job summary

An established industry player seeks a Director/Sr. Director of Regulatory Affairs to lead global regulatory strategies for innovative treatments. This pivotal role involves navigating complex regulatory landscapes, ensuring compliance, and driving submissions to health authorities. The ideal candidate will have extensive experience in regulatory affairs within the pharmaceutical sector and a passion for improving patient outcomes. Join a collaborative and fast-paced environment where your expertise will directly impact the lives of patients with genetic conditions. This is a unique opportunity to shape the future of medicine and contribute to groundbreaking therapies.

Benefits

Flexible PTO

Market-competitive compensation

Access to learning and development resources

Commitment to Diversity, Equity & Inclusion

Rapid career advancement for strong performers

Qualifications

• 15+ years of experience in pharmaceutical/biotechnology regulatory affairs.
• Expertise in regulatory strategy and submissions for drug development.

Responsibilities

• Lead the development and execution of regulatory strategies for product approval.
• Ensure compliance with global regulatory standards and guidelines.

Skills

Regulatory Strategy Development

Project Management

Communication Skills

Attention to Detail

Team Leadership

Education

Bachelor's degree in a scientific field

Advanced degree (MD, Ph.D., PharmD, MS)

Job description

Director/Sr. Director, Regulatory Affairs

Remote - United States

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
• 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

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 ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors, who execute against goals and milestones with quality, precision, and speed

Education, Experience & Skills 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

What We Offer

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn 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
• An unyielding commitment to always putting patients first. Learn more about how we do thishere
• A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• A place where you own the vision – both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
• Commitment to Diversity, Equity & Inclusion

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.

$215,000 - $315,000 USD

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