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The Vice President (VP) of Regulatory Affairs (Drug) will serve as Syncromune’s regulatory leader for the company’s drug development programs and strategic partner to executive leadership. This individual will lead the design and execution of global regulatory strategy across the product lifecycle, from IND-enabling activities through clinical development and potential BLA submission..  As a key member of the executive team, the VP will guide interactions with health authorities, and ensure that regulatory strategy is fully integrated into development, clinical, CMC, and corporate strategy.
This is a hands-on leadership role requiring strategic oversight and operational engagement in an early-stage biotechnology environment.
Principal Duties and Responsibilities include the following:.

• Develop and implement global regulatory strategies for drug development programs across preclinical development, clinical development and potential registration.
• Lead regulatory planning from IND enabling activities through clinical development and potential BLA submission.
• Advise executive leadership and the Board on regulatory risks, timelines, and strategic regulatory pathways.
• Serve as the primary regulatory voice in portfolio prioritization and development strategy, and regulatory governance discussions.
• Establish regulatory risk mitigation plans aligned with corporate objectives and development milestones.
• Lead preparation for and participation in meetings with regulatory agencies including FDA and other global health authorities (e.g., pre-IND, IND, scientific advice, end-of-phase meetings).
• Oversee preparation and submission of regulatory filings including INDs/CTAs, amendments, briefing packages, orphan applications, expedited designations and other regulatory submissions as programs advance.
• Serve as the primary contact with US and global regulatory authorities for drug related regulatory submissions.
• Drive strategies for expedited programs (e.g., Fast Track, Breakthrough Therapy, PRIME, etc., as applicable) in support of accelerated development pathways.
• Partner closely with Clinical, CMC, Nonclinical, Quality, and Commercial teams to ensure regulatory strategy is aligned with product development plans.
• Provide regulatory guidance on clinical development strategy, study design, endpoints, and labeling implications.
• Ensure regulatory requirements are integrated into CMC development plans and manufacturing strategies for future registration.
• Support due diligence activities, investor communications, and partnering discussions.
• Build scalable regulatory systems, processes, and document standards.
• Ensure timely, high-quality, compliant submissions.
• Oversee regulatory documentation lifecycle management.
• Recruit, mentor, and develop internal regulatory talent as the organization grows.
• Manage external consultants and CRO partners.
• Foster a collaborative, accountable, and mission-driven regulatory culture.
• Build infrastructure appropriate for growth from early development to later-stage operations and evolving regulatory requirements

Supervisory Responsibilities:
Directly supervises members of the Drug Regulatory Affairs team. Provides leadership, guidance, and development support to ensure execution of regulatory strategy and submissions. Responsible for recruiting, developing, and managing additional regulatory staff and external consultants as the organization and development programs expand.
Qualification Requirements:
Education:

• Masters degree required, advanced degree preferred.

Experience:

• 15 years of regulatory affairs experience in biotechnology and/or pharmaceuticals.
• Experience supporting regulatory strategy for biologics and complex therapeutic platforms preferred.
• Demonstrated success leading regulatory strategy for drug development programs from IND-enabling activities through clinical development and potential registration (e.g., BLA/NDA).
• Direct experience leading interactions with FDA and international regulatory authorities.
• Experience preparing and leading major regulatory submissions including BLA..
• Strong understanding of CMC, nonclinical, and clinical regulatory requirements supporting biologics or complex therapeutics programs

Knowledge/Skill:

• Experience in rare disease, oncology, biologics, cell/gene therapy, or other relevant modality.
• Experience in a small or emerging biotech company environment.
• Global regulatory experience including FDA and EMA, other regions a plus.
• Demonstrated ability to influence regulatory strategy and decision-making across multidisciplinary development teams.
• Strong communication, negotiation, and relationship-building skills; ability to communicate complex regulatory strategy to scientific and executive audiences.
• Excellent interpersonal communication skills; a highly communicative leader who maintains transparency both internally and externally.
• High level of integrity and professionalism with the ability to operate effectively in a fast-moving, early-stage biotechnology environment.

Working Conditions:          

• The work environment shall be either a virtual office environment, the Company headquarters in Fort Lauderdale, FL, or a combination of both.
• While performing the duties of this Job, the employee is regularly required to:
  • • Primarily sit
    • Frequent standing and walking 
    • Lifting up to 20 pounds 
    • Repetitive motions 
    • Travel up to 50% regionally, some international

Syncromune is an Equal Opportunity Employer.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:  $345K-$375K

This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans. 

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