Associate Director/Director, Regulatory Affairs - BBOT South San Francisco, CA

Bridgebiooncology; San Francisco (CA); On-site; USD 165,000 - 225,000; Full time

Job summary

An innovative biopharmaceutical company seeks an Associate Director/Director of Regulatory Affairs to lead strategic regulatory initiatives in oncology. You will oversee regulatory assessments, manage submissions, and ensure compliance with global regulations. This role requires a collaborative leader with strong communication skills and a proven track record in regulatory affairs. Join a high-performing team dedicated to advancing groundbreaking therapies targeting critical oncogenes, while enjoying a competitive rewards package and a dynamic work environment that fosters growth and innovation.

Benefits

Annual Performance Bonus

Company Equity

Generous Health Benefits

Qualifications

• Minimum 8 years experience in regulatory affairs, preferably in oncology.
• Proven experience in regulatory submissions and interactions with health authorities.

Responsibilities

• Oversee regulatory assessment and research on regulatory precedence.
• Manage regulatory communication with regulators globally.

Skills

Regulatory Affairs

Strategic Thinking

Leadership Skills

Communication Skills

Project Management

Education

Advanced Degree in Science

B.S. Degree in Science

Tools

Microsoft Office

Adobe Acrobat

Job description

Associate Director/Director, Regulatory Affairs - BBOT

BridgeBio Oncology Therapeutics (BBOT) is a clinical-stage biopharmaceutical company advancing a next generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. Initially formed as a subsidiary of BridgeBio Services, BBOT completed a $200M private financing with external investors in 2024 with the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors.

The Associate Director for BridgeBio Oncology Therapeutics Regulatory Affairs will be a strategic thinker responsible for overseeing (with support) the regulatory assessment and research on regulatory precedence to evaluate regulatory strategies for development programs focused on precision medicine.

This individual will also be responsible for application maintenance activities, amendments/supplements, and other policies and procedures as assigned. This generalist position will be part of a high-performing regulatory team working across the Oncology space within BridgeBio. The individual for this role will have collaborative and leadership skills to allow for successful cross-functional interactions within the BBOT organization.

As a key member of the Regulatory Affairs team, you will:

• Manageregulatorycommunicationwithregulators(globally)asassigned,includingsubmissioncorrespondence,andassist/leadwithinformalandformalAgencymeetings,responsestoAgencyrequests,andpre-meetingpackages.
• Ensureeffectivetimelinemanagementforpreparingandreviewingsubmissionsandapplications,includingODD,BTD,CTAs,INDs,NDAs,MAA,andallequivalentsubmissionsgloballywithintheestablishedtimelines.
• Maintainallregulatoryapplicationstoensurecompliancewithregulations,includingthepreparation,review,andexecutionofpre-andpost-marketingsubmissionactivities.
• Assistregulatoryteamsbyleadingandadvisingcross-functionalteamsonassignedregulatorystrategiesthatoptimizeandexpeditedevelopment.
• As a regulatory representative on assigned drug project teams, the incumbent will provide regulatory guidance and recommendations to the cross-functional teams that align with the company goals, international laws and regulations, and the overall regulatory strategy and implementation of the product development plan.
• ManagecoordinationwiththeRegulatoryOperationsTeam.(publishers)forassignedsubmissionstoAgenciestoensureproperdirection,preparation,andqualityQ.C.isperformedandthatallsubmissionsaretimelyandcompliantwithallAgencylaws.
• Conduct frequent Regulatory Intelligence related to the assigned programs and disseminate relevant information to senior management and cross functional teams.
• WorkwithRegulatoryAffairsleadershiptoreviewandapprovepromotionalandnon-promotionalmaterials.
• Assistwithallregulatorybusinessdevelopmenteffortsasneeded.

Education, Experience & Skills Requirements

• AdvanceddegreeorB.S.Degreeinascience-relatedfield.
• Minimum8yearsforAssociateDirectorleveland10+yearsforDirectorlevelofexperiencewithinregulatoryaffairsenvironmentpreferablyinoncology.specificallyinregulatoryCMCwithinthebiotechorpharmaceuticalindustry.
• Provenexperienceinregulatorysubmissionsandsuccessfulinteractionswithhealthauthorities.
• Experiencewithleading,preparing,andsubmittingsuccessfulsubmissions,preferablyU.S.andE.U.marketingapplicationsubmissionexperience.
• DirectexperiencewithFDAregulationsrelatingtoadvertisingandpromotionforprescriptionproductsand/orproductdevelopmentprocess,includinglabelingdevelopmentprocess,aplus.
• Evidenceofbeingacriticalstrategicthinkerwhoissolution-orientedwiththeabilitytothinkoutsideofthebox;preferencefordemonstrationofsuchwithinoncologyprograms.
• Abilitytoprioritizemultipleurgentprioritiesandexperiencewithwearingmultiplehats;managementofnon-regulatoryfunctionalactivitiesispreferred.
• ThoroughunderstandinganddemonstratedexperiencewitheCTDsubmissionrequirements,utilizingdocumenttemplates,andknowledgeofglobaloperationalregulationsandguidelines.
• Excellentwrittenandoralcommunicationskills·Demonstratedinfluencingandleadershipskills
• FluentwithMicrosoftOffice(Word,Excel,PowerPoint)andAdobeAcrobat(PDF)renderingsoftware.
• Occasionaltraveltosupportglobalregulatoryinteractionsandmeetingsasrequired.

At BridgeBio Oncology Therapeutics (BBOT), 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 Oncology Therapeutics (BBOT) is a multi-state employer, and this salary range may not reflect positions based in other states.

$165,000 - $225,000 USD

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