Braveheart Bio
Vice President, Regulatory, Safety & Pharmacovigilance
Braveheart Bio, San Francisco, California, United States, 94199
Vice President, Regulatory, Safety & Pharmacovigilance
Join to apply for the
Vice President, Regulatory, Safety & Pharmacovigilance
role at
Braveheart Bio .
Base pay range $300,000.00/yr - $397,000.00/yr
About us Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. Our lead program is a next-generation myosin inhibitor, licensed from Hengrui Pharma, being developed to transform the treatment of hypertrophic cardiomyopathy (HCM)—the most common inherited cardiac disease.
Currently in Phase 3 clinical development in China for the more common obstructive form of HCM, our candidate has demonstrated a compelling clinical profile that may position it as a best-in-class therapy with meaningful differentiation.
With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a high-profile and rapidly evolving therapeutic area.
The role The Vice President, Regulatory Affairs, Safety, & Pharmacovigilance (PV) will be responsible for defining and executing the global regulatory strategy for Braveheart's small molecule assets. This person will also establish compliant global safety and PV infrastructure to support clinical development and future commercialization.
Key responsibilities Strategic Leadership and Regulatory Submissions
Global Regulatory Strategy: Establish and execute regulatory plans for Braveheart assets from clinical development through post-approval stages, including leveraging novel and accelerated pathways such as Orphan Drug, Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval.
Agency Interaction: Act as the primary point of contact with major Health Authorities, including the FDA, EMA, and other international bodies. Lead all regulatory meetings and negotiations to secure product approvals.
Submissions Oversight: Oversee/lead/author the preparation, review, and submission of all critical regulatory documents, including INDs/CTAs, NDAs/BLAs/MAAs.
Pharmacovigilance and Safety Oversight
Global Safety Leadership: Provide strategic and functional leadership for all aspects of clinical safety and pharmacovigilance.
PV System Establishment and Oversight: Establish, manage, and provide strategic oversight for a robust, global pharmacovigilance system, ensuring the ongoing safety monitoring and reporting of all Braveheart products in development, leveraging outsourced partnerships as needed.
Risk Strategy: Lead executive decision-making for risk-benefit assessments. Oversee the development and maintenance of Risk Management Plans (RMPs).
Compliance and Inspection Readiness: Ensure the PV system and all regulatory activities comply with all applicable global regulatory guidelines and laws, maintaining an audit and inspection-ready status. Ensure the integrity and strategic compliance of all safety-related regulatory documents and submissions, including Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs).
Functional Build-Out and Infrastructure
Function Build-Out: Recruit, mentor, and manage a high-performing team across the Regulatory Affairs and the combined Safety/PV functions, scaling the organization in line with pipeline progression.
Organization Development: Establish the core structure, processes, and inter-functional relationships necessary for a high-efficiency global Regulatory and Safety organization.
System Implementation: Lead the selection and implementation of a Regulatory Information Management system (e.g., Veeva) and a validated safety database. This ensures robust, centralized, and auditable management of global regulatory data, submissions, commitments, and safety events.
Compliance and Inspection Readiness: Establish and maintain Standard Operating Procedures and quality systems for Regulatory Affairs and Safety/Pharmacovigilance, ensuring inspection readiness for domestic and international health authority audits.
Required experience & skills
Minimum of a Bachelor’s Degree; advanced degree (MS, PharmD, PhD) in a life science or related discipline is preferred.
Minimum of 15 years of progressive experience in the pharmaceutical or biotechnology industry, with at least 7 years in a leadership role in Regulatory Affairs, including established history of providing strategic oversight for associated functions such as Pharmacovigilance (PV).
Demonstrated success in leading regulatory strategy that has resulted in the successful transition of assets from Phase 2 through Phase 3 and ultimately, to global marketing authorization.
Start-up/Small Company Experience: Proven track record of building a Regulatory and/or PV function from the outset in an emerging biopharma setting is highly desirable.
Technical Proficiency: Prior experience with the strategic implementation and management of a RIM system (e.g., Veeva) and/or a PV database is highly desirable.
Exceptional ability to think strategically, define risk-based approaches, and influence executive decision-making.
Strong verbal and written communication skills for effective interactions with Health Authorities and internal stakeholders.
Proven ability to lead, motivate, and develop a specialized team in a fast-paced, high-growth environment.
Collaborative, team-oriented approach.
Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity.
Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude.
We are an equal opportunity employer.
We are committed to inclusion and diversity, and we do not discriminate on the basis of race, gender, religion, gender, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.
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Vice President, Regulatory, Safety & Pharmacovigilance
role at
Braveheart Bio .
Base pay range $300,000.00/yr - $397,000.00/yr
About us Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. Our lead program is a next-generation myosin inhibitor, licensed from Hengrui Pharma, being developed to transform the treatment of hypertrophic cardiomyopathy (HCM)—the most common inherited cardiac disease.
Currently in Phase 3 clinical development in China for the more common obstructive form of HCM, our candidate has demonstrated a compelling clinical profile that may position it as a best-in-class therapy with meaningful differentiation.
With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a high-profile and rapidly evolving therapeutic area.
The role The Vice President, Regulatory Affairs, Safety, & Pharmacovigilance (PV) will be responsible for defining and executing the global regulatory strategy for Braveheart's small molecule assets. This person will also establish compliant global safety and PV infrastructure to support clinical development and future commercialization.
Key responsibilities Strategic Leadership and Regulatory Submissions
Global Regulatory Strategy: Establish and execute regulatory plans for Braveheart assets from clinical development through post-approval stages, including leveraging novel and accelerated pathways such as Orphan Drug, Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval.
Agency Interaction: Act as the primary point of contact with major Health Authorities, including the FDA, EMA, and other international bodies. Lead all regulatory meetings and negotiations to secure product approvals.
Submissions Oversight: Oversee/lead/author the preparation, review, and submission of all critical regulatory documents, including INDs/CTAs, NDAs/BLAs/MAAs.
Pharmacovigilance and Safety Oversight
Global Safety Leadership: Provide strategic and functional leadership for all aspects of clinical safety and pharmacovigilance.
PV System Establishment and Oversight: Establish, manage, and provide strategic oversight for a robust, global pharmacovigilance system, ensuring the ongoing safety monitoring and reporting of all Braveheart products in development, leveraging outsourced partnerships as needed.
Risk Strategy: Lead executive decision-making for risk-benefit assessments. Oversee the development and maintenance of Risk Management Plans (RMPs).
Compliance and Inspection Readiness: Ensure the PV system and all regulatory activities comply with all applicable global regulatory guidelines and laws, maintaining an audit and inspection-ready status. Ensure the integrity and strategic compliance of all safety-related regulatory documents and submissions, including Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs).
Functional Build-Out and Infrastructure
Function Build-Out: Recruit, mentor, and manage a high-performing team across the Regulatory Affairs and the combined Safety/PV functions, scaling the organization in line with pipeline progression.
Organization Development: Establish the core structure, processes, and inter-functional relationships necessary for a high-efficiency global Regulatory and Safety organization.
System Implementation: Lead the selection and implementation of a Regulatory Information Management system (e.g., Veeva) and a validated safety database. This ensures robust, centralized, and auditable management of global regulatory data, submissions, commitments, and safety events.
Compliance and Inspection Readiness: Establish and maintain Standard Operating Procedures and quality systems for Regulatory Affairs and Safety/Pharmacovigilance, ensuring inspection readiness for domestic and international health authority audits.
Required experience & skills
Minimum of a Bachelor’s Degree; advanced degree (MS, PharmD, PhD) in a life science or related discipline is preferred.
Minimum of 15 years of progressive experience in the pharmaceutical or biotechnology industry, with at least 7 years in a leadership role in Regulatory Affairs, including established history of providing strategic oversight for associated functions such as Pharmacovigilance (PV).
Demonstrated success in leading regulatory strategy that has resulted in the successful transition of assets from Phase 2 through Phase 3 and ultimately, to global marketing authorization.
Start-up/Small Company Experience: Proven track record of building a Regulatory and/or PV function from the outset in an emerging biopharma setting is highly desirable.
Technical Proficiency: Prior experience with the strategic implementation and management of a RIM system (e.g., Veeva) and/or a PV database is highly desirable.
Exceptional ability to think strategically, define risk-based approaches, and influence executive decision-making.
Strong verbal and written communication skills for effective interactions with Health Authorities and internal stakeholders.
Proven ability to lead, motivate, and develop a specialized team in a fast-paced, high-growth environment.
Collaborative, team-oriented approach.
Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity.
Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude.
We are an equal opportunity employer.
We are committed to inclusion and diversity, and we do not discriminate on the basis of race, gender, religion, gender, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.
#J-18808-Ljbffr