Location: Weston, FL (near Miami and Fort Lauderdale, Florida (FL))
Function: Regulatory Affairs
Reports to: Chief Regulatory Affairs Officer
Job Summary:
The Director of Regulatory Affairs will be responsible for the preparation and management of ANDA submission 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 meet the regulatory standards of FDAs Office of Generic Drugs.
The ideal candidate will have 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.
Key Responsibilities:
Regulatory Strategy and Compliance:
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.
Regulatory Submissions:
Actively participate in the preparation, submission, and management of 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 vendor, and ensure they meet regulatory standards and guidelines.
Coordinate with cross-functional teams to compile and review submission materials.
Preparation, submission and monitoring of PLAIR activities, prior to new product launch.
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.
Cross-Functional Collaboration:
Collaborate with Pharmaceutical Development, Clinical Development, Quality Assurance, and other departments to ensure regulatory requirements are integrated into product development and lifecycle processes.
Regulatory Intelligence and Risk Management:
Conduct regulatory intelligence to anticipate and address potential regulatory challenges.
Develop and implement risk management strategies to address regulatory compliance issues.
Documentation and Reporting:
Maintain accurate and up-to-date regulatory files and documentation.
Prepare and present regulatory updates and reports to senior management and other stakeholders.
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.
Ability to work effectively in a fast-paced and dynamic environment.
Excellent organizational and project management skills.