Regulatory & Compliance Lead - Gene Therapy

Vyriad Inc.; Holiday (FL); On-site; USD 100,000 - 150,000; Full time

Benefits offered by this job

Group Healthcare Plan, including company paid dental and vision

Short- and long-term disability, life and AD&D insurance

Job summary

A biopharmaceutical company in Florida seeks a Compliance Officer to oversee regulatory affairs and compliance for gene therapy programs. This role ensures that the organization adheres to relevant laws and internal policies while guiding regulatory strategies. The ideal candidate will have at least 7 years of experience in biopharma, maintain strong relationships with regulatory bodies like the FDA, and promote a culture of compliance and integrity. Competitive benefits and a commitment to ethical standards are key aspects of this position.

Qualifications

• Minimum 7+ years of biopharma experience with strong regulatory background; gene therapy experience preferred.
• Familiarity with FDA, EMA, and ICH guidelines; experience with regulatory submissions and compliance frameworks.
• Experience managing audits, CAPA, and regulatory inspections.

Responsibilities

• Develop and implement regulatory strategies for gene therapy programs in alignment with company objectives.
• Prepare, review, and coordinate regulatory submissions (e.g., INDs, BLAs, amendments, annual reports).
• Serves as the primary liaison with FDA and other regulatory authorities.
• Monitor regulatory risks and advise leadership on mitigation strategies.
• Design, implement, and maintain company-wide compliance policies and procedures.

Skills

Strong understanding of regulatory frameworks (FDA, EMA, ICH, GCP, GMP)

Excellent verbal and written communication skills

Strong organizational skills and attention to detail

Ability to manage multiple priorities and meet deadlines

Proven ability to build relationships and influence across teams

Strategic thinker with hands-on execution capability

Education

Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Law, or related field

Compliance certification (e.g., CCEP)

Job description

A biopharmaceutical company in Florida seeks a Compliance Officer to oversee regulatory affairs and compliance for gene therapy programs. This role ensures that the organization adheres to relevant laws and internal policies while guiding regulatory strategies. The ideal candidate will have at least 7 years of experience in biopharma, maintain strong relationships with regulatory bodies like the FDA, and promote a culture of compliance and integrity. Competitive benefits and a commitment to ethical standards are key aspects of this position.