Role Overview for VP Global Regulatory Affairs – New Jersey
JRG Partners is proud to partner with a pioneering, research-driven biopharmaceutical company in their search for a visionary Vice President of Global Regulatory Affairs. Based in the vibrant life sciences hub of New Jersey, this executive leadership position offers a unique opportunity to shape the global regulatory strategy for a diverse and promising pipeline of innovative therapies. Our client is at the forefront of developing treatments for complex diseases, and this role is critical to bringing these life-changing medicines to patients worldwide.
The VP of Global Regulatory Affairs will serve as the company’s chief regulatory strategist and primary liaison with global health authorities. This individual will be a key member of the executive leadership team, providing insightful guidance on the evolving regulatory landscape and its impact on corporate objectives. You will be responsible for building and leading a world-class regulatory affairs organization, fostering a culture of excellence, collaboration, and proactive compliance. This is more than a management role; it is a chance to be the architect of a global regulatory framework that enables groundbreaking science to become approved, accessible therapies. You will be instrumental in navigating the complexities of international regulations, from early-stage development through post-market lifecycle management, ensuring that the company not only meets but exceeds global standards for safety and efficacy.
Key Responsibilities of VP Global Regulatory Affairs – New Jersey
The successful candidate will assume a broad range of responsibilities, driving regulatory excellence across the entire organization. Key duties include:
Strategic Regulatory Leadership
- Develop, articulate, and execute a forward-thinking global regulatory strategy that aligns with the company’s long-term corporate goals and product development pipeline.
- Serve as the primary regulatory advisor to the executive team, Board of Directors, and key stakeholders, providing expert analysis of regulatory risks, opportunities, and precedents.
- Anticipate and interpret changes in the global regulatory environment, translating them into actionable strategies to de-risk programs and accelerate development timelines.
- Lead regulatory due diligence for potential in-licensing, M&A, and partnership opportunities to assess viability and integration challenges.
- Oversee the regulatory affairs budget, ensuring optimal allocation of resources to support departmental and corporate objectives.
Health Authority Interactions & Submissions
- Direct the planning, preparation, and submission of high-quality regulatory dossiers, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), New Drug Applications (NDAs), Biologics License Applications (BLAs), and Marketing Authorisation Applications (MAAs).
- Act as the primary senior-level contact with global health authorities, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
- Lead the strategy and preparation for critical health authority meetings, such as pre-IND, End-of-Phase 2, pre-NDA/BLA meetings, and advisory committee hearings.
- Foster and maintain strong, collaborative relationships with regulatory agencies, building a reputation for transparency, scientific rigor, and integrity.
Regulatory Compliance & Lifecycle Management
- Ensure robust regulatory compliance across all stages of product development and commercialization, adhering to GCP, GMP, and GLP standards.
- Oversee the global labeling process, ensuring that product information is accurate, compliant, and supportive of the commercial strategy.
- Provide senior regulatory oversight for the review and approval of promotional materials, advertising, and external communications to ensure compliance with applicable regulations.
- Manage all post-approval regulatory activities, including annual reports, supplements, and variations, to maintain product licenses in all target markets.
Team Development & Cross-Functional Collaboration
- Recruit, mentor, and develop a high-performing, agile, and globally-minded regulatory affairs team.
- Foster a culture of continuous improvement, professional development, and strategic thinking within the department.
- Champion effective collaboration with cross-functional partners, including Clinical Development, R&D, Quality Assurance, Pharmacovigilance, and Commercial teams, to ensure integrated and successful program execution.
- Represent the regulatory affairs function on project teams and governance committees, ensuring the regulatory perspective is a key driver in all strategic decisions.
Requirements for the VP Global Regulatory Affairs – New Jersey
We are seeking a seasoned and accomplished leader with a proven track record of regulatory success in the biopharmaceutical industry. The ideal candidate will possess the following qualifications:
Education & Experience
- An advanced degree (PharmD, PhD, or MD) in a relevant scientific discipline is strongly preferred. A Bachelor’s or Master’s degree with extensive, relevant experience will be considered.
- A minimum of 15 years of progressive experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- At least 7-10 years of experience in a leadership role, with demonstrated success in managing and mentoring regulatory professionals.
- A proven track record of successful major regulatory submissions and approvals in key global markets (US, EU, Japan).
- Broad therapeutic area experience is highly desirable, with a preference for candidates with backgrounds in oncology, immunology, rare diseases, or cell and gene therapy.
- Direct, hands-on experience leading interactions and negotiations with the FDA and EMA is mandatory.
Skills & Competencies
- Deep and comprehensive understanding of global drug development processes, regulations, and guidelines (e.g., ICH, GCP, GMP).
- Exceptional strategic thinking and problem-solving skills, with the ability to navigate ambiguity and complexity.
- Outstanding communication skills (written and verbal), with the ability to effectively articulate complex regulatory issues to diverse audiences, including executive leadership and scientific experts.
- Demonstrated executive presence and the ability to influence and persuade stakeholders at all levels of the organization.
- Strong leadership and team-building skills, with a passion for developing talent and fostering a collaborative environment.
- High ethical standards and a commitment to scientific and regulatory integrity.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a highly competitive compensation and benefits package. This includes:
- A highly competitive base salary and annual performance-based bonus.
- A significant long-term incentive package, including stock options or restricted stock units (RSUs).
- Comprehensive, premium health, dental, and vision insurance plans for you and your eligible dependents.
- A robust 401(k) retirement savings plan with a generous company match.
- Generous paid time off (PTO), including vacation, sick leave, and company holidays.
- Paid parental leave and family support programs.
- Substantial opportunities for professional development, including conference attendance and continuing education support.
- A corporate culture that values innovation, collaboration, work-life balance, and employee well-being.
- Relocation assistance may be available for exceptional candidates.
How to Apply
This is a retained search conducted exclusively by JRG Partners. If you are a transformative regulatory leader ready to make a significant impact on a growing biopharmaceutical company, we encourage you to apply. To be considered for this confidential opportunity, please submit your resume and a cover letter detailing your qualifications and interest in the role.
JRG Partners is a leader in executive search for the healthcare and life sciences industries. We are dedicated to connecting exceptional talent with innovative companies that are changing the future of medicine. Explore more opportunities within our Top Regulatory Affairs Executive Recruiters Practice to see how we can help you advance your career.
