Vice President and Head Global Regulatory Affairs

Our Company

IGI, Inc. (Ichnos Glenmark Innovation) is a global, fully integrated clinical-stage biotechnology company focused on developing innovative biologics in oncology. Headquartered in New York, NY, IGI is advancing a robust pipeline of novel, first-in-class Multispecifics™ aimed at addressing complex diseases and treating patients holistically. Powered by its proprietary BEAT® technology platform, IGI is committed to delivering breakthrough, curative therapies to improve and extend the lives of patients battling hematological malignancies and solid tumors. For more information, visit IGInnovate.com.

IGI is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, age, religion, height, weight, sex, national origin, sexual orientation, gender identity, disability status, or any other characteristic protected by law.

Our Vision and Mission

Our vision:

Daring to imagine a world where a cure is possible. Moving beyond hope, with therapies that will forever transform medicine and lives.

Our mission:

To co-create innovative treatment solutions that make healthier living possible.

Role Overview

This executive will play a pivotal role in advancing our programs and treatment initiatives, ensuring regulatory excellence, and driving operational strategy across clinical development. The ideal candidate is a collaborative leader with deep expertise in global regulatory frameworks, clinical operations, and cross-functional alignment. The Vice President, to lead our Regulatory Affairs and Development Operations, will have 2 to 5 direct reports.

OVERALL JOB RESPONSIBILITIES

Regulatory Affairs Leadership

• Leads and executes global regulatory strategies to support IGI’s pipeline from early development through approval and commercialization.
• Member and /or co-chair of Development Leadership Team, with CMO. Member of the Research and Development Leadership team, Member of the Monthly Operation Review team (with the CEO and Board chairman)
• Members of the Joint Development Committee with AbbVie collaboration. Actively participate in the establishment of regulatory strategy and clinical development plan for lead asset in collaboration with external partner, including pivotal trial designs, meetings with regulatory authorities, and scientific advisors.
• Oversee Regulatory Affairs team (clinical and CMC reg leads, reg operations). Oversee regulatory submissions (INDs, NDAs, BLAs, CTAs) and maintain proactive engagement with agencies, including FDA, EMA, and other global bodies.
• Optimizes the development of a precision medicine approach, with integrated drug/diagnostic regulatory and submission plans, including engagement plans and mitigation strategies for regulatory agencies.
• Serve as IGI’s regulatory voice in external forums, partnerships, and advocacy efforts.
• Remains on the forefront of the relevant science, competitive landscape, and policy, including detailed competitive intelligence, and provides the Development Leadership Team with assessments of the impact of new and changing regulations on the Company’s programs.

Development Operations Oversight

• Member and /or co-chair of Development Leadership Team
• Overseeing program management function (including Development department budget) and governance meetings for pre-clinical, clinical and commercial stage compounds. May take additional function responsibility if needed.
• Lead establishment of Development department priorities and objectives
• Responsible for leading, strategizing, and overseeing the process of bringing new therapies from discovery to commercial launch, managing cross-functional teams.
• Ensuring Research and Development priorities are clearly communicated and prioritized.
• Ensures project timelines, budgets, and regulatory compliance are met.
• Involved in external communication strategy and disclosure reports for the company
• Lead internal and external collaboration for key initiatives in the clinical development organization

Executive Leadership & Culture Stewardship

• Build and mentor high-performing teams that reflect IGI’s values of compassion, innovation, and continuous improvement.
• Contribute to enterprise-wide strategic planning, budgeting, and leadership alignment.
• Represent IGI’s mission and impact in board meetings, investor presentations, and strategic partnerships.

KNOWLEDGE, SKILLS AND ABILITIES

Education

• Advanced degree in life sciences, pharmacy, or related field (PhD, PharmD).

Knowledge and Skills (Functional / Technical)

• 15 years of progressive experience in regulatory affairs and clinical development, ideally in oncology.
• Oncology experience required; experience with FDA, EU, and other regulatory agencies, including emerging markets, is highly desired.
• At least 10 years' experience in managing a regulatory team.
• Proven ability in leading and directing regulatory affairs activities from pre-IND through global marketing application (e.g., NDA/BLA/MAA).
• Direct experience in developing strategy and leading teams through interactions with health authorities.
• Track record of issue resolutions with main regulatory authorities.
• Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.
• Experience with communicating regulatory strategy, issues, and risks in written and verbal formats to the regulatory senior leadership team and other governing bodies.
• Skilled in change management, vendor relations, and cross-functional alignment.
• Strategic thinker with a bias for action and a commitment to patient impact.
• Experience in co-development of biotech-pharma is a plus