About the Company:

Arevna is partnering with a fast-growing biopharmaceutical company based in the beautiful state of Texas. This innovative organization is expanding its operations and is looking for an experienced Quality and Regulatory Director to join their team.

Key Requirement:

Candidates must have direct experience in the development of generics and a proven track record of filing multiple ANDAs (Abbreviated New Drug Applications).

Role Overview:

As the Quality and Regulatory Director, you will lead the quality assurance function and oversee regulatory compliance efforts. Your role will be pivotal in ensuring the company adheres to FDA standards, with a focus on Chemistry, Manufacturing, and Controls (CMC). You will be responsible for developing and maintaining quality systems, managing regulatory submissions, and setting strategic direction for a high-performing QA and regulatory team.

Key Responsibilities:

• Oversee and enhance quality systems, including SOPs, CAPA, supplier management, audits, and document control.
• Lead the preparation, submission, and lifecycle management of ANDAs, ensuring compliance with regulatory requirements.
• Collaborate with cross-functional leadership to maintain adherence to FDA/EMA regulations and GMP/GLP/ICH guidelines.
• Conduct risk assessments, manage quality metrics, and drive continuous improvement initiatives.
• Act as the primary QA and regulatory point of contact during internal audits, supplier audits, and regulatory inspections.
• Provide strategic guidance on CMC-related issues to ensure successful regulatory filings and product launches.

Qualifications:

• Bachelor’s degree in a relevant scientific or technical field. Advanced degree preferred.
• 7+ years of quality assurance experience, including at least 4+ years in a regulated pharmaceutical environment.
• Expertise in generics development and CMC processes, with a proven record of filing multiple ANDAs.
• Strong understanding of FDA/EMA regulations, GMP, GLP, GCP, and ICH guidelines.
• Demonstrated experience in CAPA management, root cause analysis, and risk assessment methodologies.
• Exceptional organizational, leadership, and communication skills with the ability to influence cross-functional teams.