Senior Manager/Associate Director, Regulatory Affairs

The role

This person will develop and execute regulatory strategies for development programs. They will lead global regulatory submissions and collaborate with cross-functional project teams.

What you will do

• Develop and execute regional regulatory strategies
• Plan, compile, review, and submit regulatory documents including INDs, CTAs, and NDAs
• Represent Regulatory at cross functional team meetings
• Provide strategic regulatory guidance internally on study-level decision-making
• Manage tracking of regulatory/ethics submissions and approvals across all studies
• Facilitate FDA or other Health Authority meetings
• Collaborate with Project Team representatives in the planning of regulatory documents
• Develop, maintain, and communicate timelines for regulatory submissions
• Participate in the review of critical documents like protocols, ICFs, IBs, CSRs, and DSURs
• Coordinate with CROs and other vendors to plan and finalize submissions

Required qualifications

• BA/BS degree in the biological or physical sciences
• Minimum of 3 years of industry experience for Senior Manager level
• Knowledge of US FDA and international pharmaceutical guidance, regulations (e.g., 21 CFR, ICH, GCP, GMP, EMA), drug development process, and industry-standard practices
• Experience supporting eCTD-formatted submissions, e.g., INDs, NDAs/BLAs, MAAs, annual reports, amendments, and supplements
• Experience coordinating or supporting responses to health authorities or other critical submission projects
• Proficient in written, oral, and interpersonal communications in English
• Ability to work in close collaboration with colleagues
• Capability to provide strategic guidance on regulatory and program-related issues
• Ability to problem solve unexpected problems or roadblocks
• High attention to detail
• Proficient user of standard MS Office suite
• Experience using Veeva electronic document management systems and document review tools

Nice to have

• Advanced degree (eg, PharmD or PhD)
• Experience interacting with CROs in the management of US eCTD IND submissions and ex-US CTAs towards clinical trial activations

Benefits

• 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
• 100% employer-paid medical, dental, and vision premiums for you and your dependents
• Health Savings Account (HSA) with annual employer contributions
• Flexible Spending Accounts (FSA)
• Fertility & family-forming benefits
• Expanded mental health support
• Flexible, “take-what-you-need” paid time off and company-paid holidays

About the company

BridgeBio uses a model of pooling projects and promising early-stage research from academia to reduce risk and unleash innovation. They develop medicines for patients with unmet needs in rare diseases.