Senior Manager/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 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. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

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. The candidate will have demonstrated the ability to work independently or with limited oversight, along with knowledge of regulatory requirements and guidelines, and will apply that knowledge to daily work while managing critical projects as part of an interdisciplinary team. Level (Senior Manager or Associate Director) will be determined by experience and scope of responsibility.

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

• Plan, compile, review, and submit regulatory documents, including initial INDs/CTAs/NDAs and amendments or supplements, independently or with limited oversight
• Represent Regulatory at cross functional team meetings.
• Lead study related regulatory activities:

• Act as the regulatory study representative at cross-functional team meetings
• Provides strategic regulatory guidance internally on study-level decision-making
• Keeps study team informed of regulatory activities in the context of study team management meetings
• Provides ownership of study-level global regulatory activities, including clinical trial application (CTA) and IND submissions, reviews and approval of investigator document packages and associated FDA submissions, and manages 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.
• Develop, maintain, and communicate timelines for regulatory submissions to ensure timely delivery of regulatory documentation
• Participate in the review of critical documents such as protocols, ICFs, IBs, CSRs, and DSURs to ensure compliance with relevant regulations and guidance (e.g., ICH, FDA, EMA) before submission
• Coordinate with CROs and other vendors to plan and finalize submissions to health authorities per regulations and guidelines
• Manage and track queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses, and provides periodic status updates regarding unfulfilled conditions/commitments
• Input to global regulatory submissions and strategic planning as applicable
• Contribute to the maintenance of regulatory databases, including submission and correspondence logs
• Review, write, and present regulatory guidelines and SOPs as needed to support high-quality submissions and adherence to regulatory requirements
• Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration

Education, Experience & Skills Requirements

• BA/BS degree in the biological or physical sciences, advanced degree (eg, PharmD or PhD preferred);
• Relevant pharmaceutical industry experience, including experience in regulatory affairs; a minimum of 3 years of industry experience is generally required for the Senior Manager level, with greater experience and scope of responsibility expected at the Associate Director level. An equivalent combination of education and experience may be considered.
• Knowledgeable of US FDA and international pharmaceutical guidance, regulations (e.g., 21 CFR, ICH, GCP, GMP, EMA), drug development process, and industry-standard practices

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