Careers

Compliance Officer

Salary range:

$147,000 - $197,000

Full-time, exempt

The Compliance Officer serves as the organization’s primary resource for both regulatory affairs and compliance oversight. This role ensures adherence to applicable laws, regulations, and internal policies while guiding regulatory strategy for gene therapy programs. The Compliance Officer will act as a strategic partner and hands-on contributor, promoting integrity, ethical standards, and regulatory success across the company.

Duties and responsibilities

Regulatory Affairs

• 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) with support from external consultants as needed.
• Serve as the primary liaison with FDA and other regulatory authorities; lead preparation for meetings and responses.
• Monitor regulatory risks and advise leadership on mitigation strategies.
• Stay current with evolving regulations and guidance impacting gene therapy and communicate implications to stakeholders.

Compliance & Ethics

• Design, implement, and maintain company-wide compliance policies, procedures, and training programs.
• Oversee internal compliance activities, including audits, CAPA, and risk assessments.
• Ensure adherence to GCP, GMP, and ethical standards across operations.
• Coordinate and manage regulatory inspections and internal readiness activities.
• Promote a culture of compliance and integrity throughout the organization.

Other Duties as Assigned

Education and experience requirements

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Law, or related field.
• Compliance certification (e.g., CCEP) preferred.
• 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.

Required skills and/or qualifications

• 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.

Physical requirements

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.

Benefits

• Group Healthcare Plan, including company paid dental and vision.
• Short- and long-term disability, life and AD&G insurance.
• Simple IRA with employer match
• Educational assistance program
• Holiday and PTO