Vice President Regulatory Affairs

• 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

• Masters degree required, advanced degree preferred.

• 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

• 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.

• 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. 

Powered by JazzHR