Regulatory Affairs Manager - Katalyst Healthcares & Life Sciences

• 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.

• 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 guidance.

• 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 Labelling 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.

• 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.

Requirements:

• 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.