Director of Regulatory Affairs

Director of Regulatory Affairs

Direct Hire Full-Time Role

Location: Weston, FL - Onsite Role

Job Summary:

As a Director of Regulatory Affairs, you will prepare and manage ANDA submissions and oversee and manage all ANDA regulatory activities pre- and post-submission. This role is critical in ensuring that products meet all regulatory requirements and the regulatory standards of the FDA's Office of Generic Drugs. We require a candidate with a deep understanding of regulatory affairs related to generic drug development and dossier submission, excellent leadership skills, and a proven track record of successful regulatory submissions and interactions with regulatory agencies.

Duties and Responsibilities:

• Develop and implement regulatory strategies for generic product development, product modifications, and lifecycle management.
• Ensure all regulatory activities align with company goals and compliance requirements.
• Monitor and interpret regulatory changes and trends to ensure ongoing agreement with regulatory guidances.
• Actively participate in preparing, submitting, and managing regulatory filings, primarily focusing on ANDAs submitted to FDA.
• Prepare, review, and submit Controlled Correspondences to FDA.
• Manage regulatory correspondence in the US (OGD, User fee staff, drug listing) and EU/UK Agencies as needed.
• Participate in and oversee the preparation of dossiers with external vendors and ensure they meet regulatory standards and guidelines.
• Coordinate with cross-functional teams to compile and review submission materials.
• Prepare, submit, and monitor PLAIR activities before new product launches.
• Manage ANDA Labeling activities.
• Serve as the primary liaison with regulatory authorities.
• Manage and facilitate meetings and communications with regulatory agencies.
• Address regulatory queries and issues promptly and effectively.
• Collaborate with Pharmaceutical Development, Clinical Development, Quality Assurance, and other departments to ensure regulatory requirements are integrated into product development and lifecycle processes.
• Conduct regulatory intelligence to anticipate and address potential regulatory challenges.
• Develop and implement risk management strategies to address regulatory compliance issues.
• Maintain accurate and up-to-date regulatory files and documentation.
• Prepare and present regulatory updates and reports to senior management and other stakeholders.

Requirements and Qualifications:

• Bachelor's degree in a scientific discipline; advanced degree (MS, PhD) preferred.
• Minimum of 7 years of experience in regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of OGD regulatory requirements and standards.
• Proven experience with regulatory submissions and interactions with regulatory agencies.
• Self-starter with strong hands-on experience
• Strong leadership, communication, and interpersonal skills.
• Able to work effectively in a fast-paced and dynamic environment.
• Excellent organizational and project management skills

Desired Skills and Experience

Regulatory Affairs, ANDA submission, FDA submission, OGD, PLAIR

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