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Head of Regulatory Affairs

2 months ago

Weston, United States Transpire Bio Full time

Job Title: Director of Regulatory Affairs

Location: Weston, FL

Function: Regulatory Affairs

Reports to: Chief Regulatory Affairs Officer

Position Overview:

The Director of Regulatory Affairs will oversee the preparation and management of ANDA submissions, ensuring compliance with all regulatory requirements. This pivotal role is essential for maintaining adherence to the standards set forth by the FDA's Office of Generic Drugs.

The successful candidate will possess extensive knowledge of regulatory affairs pertaining to generic drug development, demonstrate exceptional leadership capabilities, and have a proven history of successful regulatory submissions and effective communication with regulatory bodies.

Key Responsibilities:

Regulatory Strategy and Compliance:

  • Formulate and execute regulatory strategies for the development of generic products, modifications, and lifecycle management.
  • Ensure alignment of all regulatory activities with corporate objectives and compliance mandates.
  • Stay informed on regulatory changes and trends to maintain compliance with guidance documents.

Regulatory Submissions:

  • Engage in the preparation, submission, and oversight of regulatory filings, focusing on ANDAs submitted to the FDA.
  • Prepare, review, and submit Controlled Correspondences to the FDA.
  • Manage regulatory communications within the US and with EU/UK agencies as necessary.
  • Collaborate with external vendors to prepare dossiers that meet regulatory standards.
  • Coordinate with cross-functional teams to compile and assess submission materials.
  • Oversee PLAIR activities in preparation for new product launches.
  • Manage ANDA labeling processes.
  • Act as the primary contact for regulatory authorities.
  • Facilitate meetings and communications with regulatory agencies.
  • Promptly address regulatory inquiries and issues.

Cross-Functional Collaboration:

Work closely with departments such as Pharmaceutical Development, Clinical Development, and Quality Assurance to ensure that regulatory requirements are integrated into product development and lifecycle processes.

Regulatory Intelligence and Risk Management:

Conduct regulatory intelligence to foresee and mitigate potential regulatory challenges. Develop and implement strategies for managing compliance risks.

Documentation and Reporting:

Maintain comprehensive and current regulatory files and documentation. Prepare and present regulatory updates and reports to senior management and stakeholders.

Qualifications:

  • Bachelor's degree in a scientific field; advanced degree (MS, PhD) preferred.
  • A minimum of 7 years of experience in regulatory affairs within the pharmaceutical sector.
  • Thorough understanding of OGD regulatory standards and requirements.
  • Demonstrated experience with regulatory submissions and agency interactions.
  • Self-motivated with substantial hands-on experience.
  • Strong leadership, communication, and interpersonal skills.
  • Ability to thrive in a fast-paced and dynamic environment.
  • Excellent organizational and project management abilities.