Global Life Science Hub
Senior Vice President Regulatory Affairs
Global Life Science Hub, Trenton, New Jersey, United States
Senior Vice President Regulatory Affairs
Global Senior Vice President, Regulatory Affairs | Biologics | New Jersey
Global Life Science Hub is partnered with a fast‑sizing biologics organization making a major investment into advanced manufacturing as it moves from development success into sustained commercial execution. With multiple regulatory wins secured, a deep late‑stage pipeline, and significant GMP operations coming online, the company is entering a phase where global regulatory strategy will directly shape commercial scale, supply readiness, and long‑term portfolio value.
We are seeking a Senior Vice President of Regulatory Affairs to step into a highly visible global leadership role following a planned leadership transition. This executive will own worldwide regulatory strategy across development, manufacturing, and commercial operations, build and lead an international Regulatory Affairs organization, and act as the most senior regulatory voice with the FDA and global health authorities as the business accelerates toward multi‑product commercialization.
Responsibilities
Develop global regulatory strategies to gain earliest possible regulatory approval in the US and other international markets, with product labeling that sets a high hurdle for any competitors in the field.
Develop effective working relationships with FDA, EMEA, and other regulatory authorities, such as coordinating activities for meetings and leading approval negotiations.
Manage the compilation, submission and maintenance of INDs, BLAs and amendments.
Build and effectively lead a high‑performing Regulatory team.
Identify gaps in product development plans that may pose regulatory issues and come up with novel endpoint development strategies.
Develop and plan innovative regulatory strategies for label enhancements and life‑cycle product management.
Act as the independent subject matter expert in giving guidance to project teams, departments, and management, while considering company‑wide implications.
Provide regulatory input to the business development group in the assessment of new product acquisition and product out‑licensing candidates.
Manage post‑market surveillance requirements for commercial products by assessing regulatory categorization of adverse events reported during use in the population and preparing/filing expedited safety and periodic safety reports to FDA.
Perform other functions as required or assigned.
Comply with all company policies and standards.
Experience / Qualifications
Master’s degree in a scientific discipline required; advanced degree (PhD or PharmD) strongly preferred.
15+ years of industry experience with a minimum of 10 years in senior‑level Regulatory Affairs leadership at a global level.
Proven end‑to‑end regulatory leadership on a full monoclonal antibody program, from development through BLA/MAA submission and approval.
Deep regulatory expertise across biologics and biosimilars, with a demonstrated record of successful major global submissions and life‑cycle management.
Broad experience spanning clinical, CMC, and commercial regulatory affairs, with the ability to integrate regulatory strategy across the full product lifecycle.
Demonstrated success leading regulatory strategy for products moving into commercial manufacturing and global supply.
Extensive experience serving as the sponsor’s lead representative with health authorities, including direct negotiation with FDA, EMA and other global agencies.
Highly strategic decision‑maker with the confidence to take and defend complex regulatory positions at the executive level.
Strong scientific and medical foundation with a deep understanding of evolving global regulatory policy and guidance.
Proven ability to build, scale, and lead high‑performing global regulatory teams while operating effectively in highly cross‑functional environments.
Recognized for unquestionable ethics, professional integrity, and the ability to inspire and lead senior‑level teams.
Exceptional written and verbal communication skills with the ability to influence at board, executive, and agency levels.
Track record of generating innovative regulatory solutions in complex or non‑traditional development programs.
Demonstrated success operating in entrepreneurial, small‑to‑mid‑size organizations, balancing strategic leadership with hands‑on execution.
Location New Jersey, United States
Compensation $300,000.00 – $400,000.00 (salary range)
#J-18808-Ljbffr
Global Life Science Hub is partnered with a fast‑sizing biologics organization making a major investment into advanced manufacturing as it moves from development success into sustained commercial execution. With multiple regulatory wins secured, a deep late‑stage pipeline, and significant GMP operations coming online, the company is entering a phase where global regulatory strategy will directly shape commercial scale, supply readiness, and long‑term portfolio value.
We are seeking a Senior Vice President of Regulatory Affairs to step into a highly visible global leadership role following a planned leadership transition. This executive will own worldwide regulatory strategy across development, manufacturing, and commercial operations, build and lead an international Regulatory Affairs organization, and act as the most senior regulatory voice with the FDA and global health authorities as the business accelerates toward multi‑product commercialization.
Responsibilities
Develop global regulatory strategies to gain earliest possible regulatory approval in the US and other international markets, with product labeling that sets a high hurdle for any competitors in the field.
Develop effective working relationships with FDA, EMEA, and other regulatory authorities, such as coordinating activities for meetings and leading approval negotiations.
Manage the compilation, submission and maintenance of INDs, BLAs and amendments.
Build and effectively lead a high‑performing Regulatory team.
Identify gaps in product development plans that may pose regulatory issues and come up with novel endpoint development strategies.
Develop and plan innovative regulatory strategies for label enhancements and life‑cycle product management.
Act as the independent subject matter expert in giving guidance to project teams, departments, and management, while considering company‑wide implications.
Provide regulatory input to the business development group in the assessment of new product acquisition and product out‑licensing candidates.
Manage post‑market surveillance requirements for commercial products by assessing regulatory categorization of adverse events reported during use in the population and preparing/filing expedited safety and periodic safety reports to FDA.
Perform other functions as required or assigned.
Comply with all company policies and standards.
Experience / Qualifications
Master’s degree in a scientific discipline required; advanced degree (PhD or PharmD) strongly preferred.
15+ years of industry experience with a minimum of 10 years in senior‑level Regulatory Affairs leadership at a global level.
Proven end‑to‑end regulatory leadership on a full monoclonal antibody program, from development through BLA/MAA submission and approval.
Deep regulatory expertise across biologics and biosimilars, with a demonstrated record of successful major global submissions and life‑cycle management.
Broad experience spanning clinical, CMC, and commercial regulatory affairs, with the ability to integrate regulatory strategy across the full product lifecycle.
Demonstrated success leading regulatory strategy for products moving into commercial manufacturing and global supply.
Extensive experience serving as the sponsor’s lead representative with health authorities, including direct negotiation with FDA, EMA and other global agencies.
Highly strategic decision‑maker with the confidence to take and defend complex regulatory positions at the executive level.
Strong scientific and medical foundation with a deep understanding of evolving global regulatory policy and guidance.
Proven ability to build, scale, and lead high‑performing global regulatory teams while operating effectively in highly cross‑functional environments.
Recognized for unquestionable ethics, professional integrity, and the ability to inspire and lead senior‑level teams.
Exceptional written and verbal communication skills with the ability to influence at board, executive, and agency levels.
Track record of generating innovative regulatory solutions in complex or non‑traditional development programs.
Demonstrated success operating in entrepreneurial, small‑to‑mid‑size organizations, balancing strategic leadership with hands‑on execution.
Location New Jersey, United States
Compensation $300,000.00 – $400,000.00 (salary range)
#J-18808-Ljbffr