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
• Demonstrated experience supporting eCTD-formatted submissions, e.g., INDs, NDAs/BLAs, MAAs, annual reports, amendments, and supplements
• Has successfully coordinated or supported responses to health authorities or other critical submission projects while maintaining agreed timelines
• Proficient in written, oral, and interpersonal communications in English
• Ability to work in close collaboration with colleagues in the regulatory department and throughout the development organization
• Capability to provide strategic guidance on regulatory and program-related issues
• Ability to problem solve unexpected problems or roadblocks that arise
• High attention to detail; ability to organize, prioritize, and delegate assigned projects
• Experience interacting with CROs in the management of US eCTD IND submissions and ex-US CTAs towards clinical trial activations preferred
• Proficient user of standard MS Office suite (e.g., Word, Excel, PowerPoint), experience using Veeva electronic document management systems and document review tools

Where You’ll Work

This is a U.S.-based remote role that will require occasional, as-needed travel to our San Francisco or Palo Alto offices.

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 $160,000—$225,000 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

• Market-leading compensation

• 401(k) with employer match

• Employee Stock Purchase Program (ESPP)

• Pre-tax commuter benefits (transit and parking)

• Referral bonus for hired candidates

• Subsidized lunch and parking on in-office days

Health & Well-Being

• 100% employer-paid medical, dental, and vision premiums for you and your dependents

• Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)

• Fertility & family-forming benefits

• Expanded mental health support (therapy and coaching resources)

• Hybrid work model with flexibility

• Flexible, “take-what-you-need” paid time off and company-paid holidays

• Comprehensive paid medical and parental leave to care for yourself and your family

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, & BetterUp Coaching

• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

By applying, you acknowledge that BridgeBio will process your personal information as described in ourGlobal Candidate Privacy Notice.

Originally posted on Himalayas