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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