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Regulatory Director

2 months ago

Princeton, New Jersey, United States SUN PHARMA Full time

Job Summary

The Director, Global Regulatory Lead will be responsible for leading the development and execution of regulatory strategies for assigned brand programs. This includes providing regulatory pathways for product development, interacting with regulatory agencies, and communicating with stakeholders.

Key Responsibilities

  • Develop and execute regulatory strategies for assigned brand programs.
  • Provide regulatory pathways for product development, including IND, CTA, NDA, and BLA submissions.
  • Interact with regulatory agencies, including the FDA, to ensure compliance with regulations and guidelines.
  • Communicate with stakeholders, including internal teams and external partners, to ensure alignment on regulatory strategies.
  • Stay up-to-date on regulatory agency regulations, directives, guidelines, and policies that impact product development.
  • Identify and communicate regulatory issues to management that could impact product submission, approval, and launch.
  • Set and monitor submission timelines with key stakeholders.
  • Facilitate and lead communications with Regulatory Agencies/Health Authority as applicable.
  • Ensure communication with the regulatory body is in accordance with established procedure within the department.
  • Develop and manage relationships with external regulatory agencies, industry groups, and business partners.
  • Review audit reports, Regulatory Agency inspection reports, and responses to inspection observations as received.
  • Compile, prepare, and review regulatory submissions to regulatory agencies as applicable.
  • Conduct department-level training to educate regulatory strategists and other roles on regulatory requirements, policies, and procedures.
  • Participate in authoring and/or reviewing departmental procedures as applicable.

Qualifications

  • Post-graduation in Clinical Pharmacy or similar is required.
  • PhD will be preferable.
  • Minimum of 10+ years of experience within global regulatory affairs in the pharmaceutical/biotech industry.
  • A thorough understanding of NCE drug development process and regulatory requirements for products across various routes of administration.
  • Direct experience authoring and filing IND, CTA, NDA, and BLA's across major regulated markets and a knowledge of developing biologics regulations.