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Senior Medical, Legal, and Regulatory Specialist at BridgeBio Pharma: 100% Remote (US)

Title: Senior Medical, Legal, and Regulatory Specialist

Location: Remote - USA

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

Reporting to the Associate Director, Medical Affairs, the Sr MLR Specialist manages the end-to-end MLR review process for BridgeBio Neuromuscular. The Sr MLR Specialist serves as subject matter expert for the document management system that supports MLR review and ensures that administrative and program management support for MLR operates effectively and in full compliance with internal policies and external regulations.

The ideal candidate has strong planning, prioritization, organization and follow-through, along with executive functioning, negotiating skills, and the confidence to hold senior stakeholders accountable to established timelines. They keep a high-volume review process moving across Medical, Legal, Regulatory, and Commercial without sacrificing documentation quality.

Responsibilities

Owns the day-to-day administration and execution of designated MLR processes while supporting the development and implementation of the MLR process, procedures, and related SOPs and work practices – identifies and drives areas for process improvement.
Serves as a business administrator for the document management platform (Veeva PromoMats and MedComms) – leads configuration and implementation, and builds reports to track review activity and inform process improvements
Serves as primary point of contact for scheduling and facilitating MLR meetings, including capturing comments, driving issue resolution, and keeping projects on schedule against established timelines
Prepares and scribes clear meeting minutes, decision logs and action items; circulates them for approval, and files the approved record
Performs quality control on submitted materials, including verification of final documents against the approved version
Gathers and maintains the forward-looking submission forecast with brand and medical sponsors, and translates it into review capacity planning
Support or oversee preparation and filing of regulatory agency submissions (such as FDA Form 2253) where applicable.
Serves as the primary resource for internal stakeholders and agency partners on MLR processes, delivering training and day-to-day guidance on best practices for compliant content creation, submission requirements, and system workflows.

Where You’ll Work

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

Who You Are

Minimum bachelor’s degree in a life science, communications, or related field
Minimum of 5-7 years in pharmaceutical, biotechnology, or medical device, with at least 3 to 4 years of direct exposure to promotional review, regulatory affairs, medical affairs, or commercial operations
Experience with Veeva or a comparable electronic document and promotional review management system
Working knowledge of FDA OPDP expectations for promotional materials, including fair balance, substantiation, and use of references
Strong written communication — specifically, the ability to prepare meeting minutes, decisions, and action items that someone who was not in the room can understand and act on
Demonstrated ownership of recurring, deadline-driven, cross-functional meetings, with proven ability to manage multiple priorities and hold timelines
Highly organized and quality-oriented with consistent attention to detail; follows established procedures while adapting to new practices and shifting priorities
Experience supporting the review of promotional and medical materials, including document control, records retention, and audit readiness
Sound judgment and discretion when handling confidential, regulated, and commercially sensitive information

Preferred

Direct experience with Veeva PromoMats or Veeva Vault
Prior MLR, PRC, or MRC coordinator/specialist experience
Product launch experience
Familiarity with agency workflows and creative production timelines

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

$115,000 - $140,000 USD

As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

For BridgeBio Full-Time U.S Based Roles:

Financial & Rewards