Director of Regulatory Affairs

2 months ago

Weston, United States Bayside Solutions Full time

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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