Confidential
Vice President of Regulatory Affairs
About the Company
Ambitious biotechnology (BioTech) company specializing in circular RNA technology & LNP delivery solutions
Industry Biotechnology Research
Type Privately Held, VC-backed
Founded 2019
Employees 51-200
Funding $200+ million
About the Role
The Company is in search of a Vice President of Regulatory Affairs to spearhead the development and execution of regulatory strategies for the approval of novel drug candidates. The successful candidate will be tasked with leading global regulatory activities across all programs, with a focus on preclinical and clinical development, CMC, and commercialization. Key responsibilities include driving the global regulatory strategy, overseeing the preparation of all regulatory filings, and ensuring alignment with clinical trial requirements and company milestones. The role demands a leader with a strong track record in successful regulatory submissions and approvals, particularly in the areas of RNA, lipid nanoparticle, cell, and gene therapies, and hands-on experience with Phase 1 regulatory interactions and filings in the US, EU, and Asia.
Applicants for the Vice President of Regulatory Affairs position at the company should have a minimum of 15 years' experience in regulatory affairs within the biotechnology or pharmaceutical industry, with at least 8 years in leadership roles. The ideal candidate will possess a deep understanding of regulatory guidance, quality standards, and global health authority expectations, particularly in the specified therapeutic areas. A proven ability to build and lead high-performing regulatory teams, as well as exceptional communication, negotiation, and strategic planning skills, are essential. The role requires a committed leader with the ability to mentor and influence across various levels and functions, and who is dedicated to the mission of advancing healthcare through innovative regulatory practices.
Hiring Manager Title Chief Medical Officer
Travel Percent Less than 10%
Functions
General Management Operations Strategy
About the Company
Ambitious biotechnology (BioTech) company specializing in circular RNA technology & LNP delivery solutions
Industry Biotechnology Research
Type Privately Held, VC-backed
Founded 2019
Employees 51-200
Funding $200+ million
About the Role
The Company is in search of a Vice President of Regulatory Affairs to spearhead the development and execution of regulatory strategies for the approval of novel drug candidates. The successful candidate will be tasked with leading global regulatory activities across all programs, with a focus on preclinical and clinical development, CMC, and commercialization. Key responsibilities include driving the global regulatory strategy, overseeing the preparation of all regulatory filings, and ensuring alignment with clinical trial requirements and company milestones. The role demands a leader with a strong track record in successful regulatory submissions and approvals, particularly in the areas of RNA, lipid nanoparticle, cell, and gene therapies, and hands-on experience with Phase 1 regulatory interactions and filings in the US, EU, and Asia.
Applicants for the Vice President of Regulatory Affairs position at the company should have a minimum of 15 years' experience in regulatory affairs within the biotechnology or pharmaceutical industry, with at least 8 years in leadership roles. The ideal candidate will possess a deep understanding of regulatory guidance, quality standards, and global health authority expectations, particularly in the specified therapeutic areas. A proven ability to build and lead high-performing regulatory teams, as well as exceptional communication, negotiation, and strategic planning skills, are essential. The role requires a committed leader with the ability to mentor and influence across various levels and functions, and who is dedicated to the mission of advancing healthcare through innovative regulatory practices.
Hiring Manager Title Chief Medical Officer
Travel Percent Less than 10%
Functions
General Management Operations Strategy