Job Description

A leader in the advanced cell therapy space is seeking a Director of Regulatory Affairs to join their growing team. This company is transforming the treatment of serious injuries and degenerative conditions with multiple approved products and an expanding pipeline to redefine standards in regenerative medicine.

The Director of Regulatory Affairs is responsible for leading regulatory strategy and execution to support product development and commercialization goals. This role involves managing regulatory submissions, guiding cross-functional teams, and ensuring compliance with applicable regulations. The Director will operate with a high degree of independence and oversee a team of regulatory professionals.

Responsibilities:

• Lead and implement regulatory strategies aligned with corporate objectives.
• Oversee the preparation and submission of regulatory documents including marketing applications, supplements, amendments, and variations for drugs, biologics, and/or medical devices.
• Ensure ongoing compliance with regulatory requirements in collaboration with internal teams and external partners.
• Serve as the primary liaison with regulatory authorities, including participation in meetings and correspondence.
• Provide regulatory guidance to cross-functional teams throughout the product lifecycle.
• Monitor and interpret evolving regulatory requirements and communicate key updates to leadership.
• Contribute to the development and refinement of internal regulatory processes and SOPs.
• Manage and mentor a team of regulatory professionals, fostering a culture of accountability, collaboration, and continuous improvement.
• Define performance metrics and ensure alignment with departmental and organizational goals.
• Support staff development through coaching, training, and performance feedback.
• Oversee the work of external consultants and vendors as needed.

Qualifications

• Bachelor's degree in a scientific discipline required; advanced degree preferred.
• Minimum of 10 years of regulatory affairs experience in the life sciences industry.
• Proven leadership experience managing regulatory teams and projects.
• Experience with regulatory submissions for drugs, biologics, and/or medical devices.
• Familiarity with combination products and/or botanical products is a plus.
• Knowledge of FDA regulations, including advertising and promotional review processes.
• Proficiency with eCTD structure and regulatory documentation.
• Strong written and verbal communication skills.
• Ability to work effectively in cross-functional teams and with external stakeholders.
• Detail-oriented with strong organizational and problem-solving skills.

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