Global Life Science Hub · 4 weeks ago
Senior Vice President Regulatory Affairs
New Jersey, United States
Full-time
Onsite
Director/Executive
15+ years expGlobal Life Science Hub is partnered with a fast-scaling biologics organization making a major investment into advanced manufacturing. They are now seeking a Senior Vice President of Regulatory Affairs to own worldwide regulatory strategy across development, manufacturing, and commercial operations, and lead an international Regulatory Affairs organization.
Staffing & Recruiting
Hiring Manager
Joshua Leggett
Responsibilities
Develop global regulatory strategies to gain earliest possible regulatory approval in US and other international markets, with product labelling 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, BLA's and amendments
Build and effectively lead 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 companywide 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 prepare/file expedited safety and periodic safety reports to FDA
Performs other functions as required or assigned
Complies with all company policies and standards
Qualification
Required
Master's degree in a scientific discipline required
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 lifecycle 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-sized organizations, balancing strategic leadership with hands-on execution
Preferred
advanced degree (PhD or PharmD) strongly preferred
Company
Global Life Science Hub
The Global Life Science Hub offers functional services and consulting, driven by a solid mission to accelerate, strengthen, and enhance global clinical trials.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase