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Director‚ Regulatory Affairs

Job Description
Demonstrated ability in leading the development of sound and effective regulatory strategies. Identify and communicate potential risks associated with strategy scenarios. Responsible for implementation of clinical strategies for ongoing projects.

Lead creative and constructive interactions with regulatory agencies to ensure that all projects have clearly defined regulatory paths and milestones leading to successful filings and approvals.

Plan and lead compilation of all relevant regulatory filings and responses to health authorities. Responsible for preparation and submission of regulatory documentation to FDA and international health authorities‚ as appropriate. Responsible for assuring the quality‚ content and format of regulatory submissions and for communication/teamwork with project team members. Manage the assembly‚ support the review and submission of regulatory documentation such as new INDs/CTAs‚ major and routine amendments to INDs.

Advise the project teams on regulatory matters for GMP‚ GLP‚ and GCP aspects of all research‚ development (manufacturing and operations)‚ pre-clinical and clinical.

Develops and implements policies in compliance (cGMP and GLP) and management of quality systems; ensure compliance with SOPs

Ensure consistency/completeness/adherence to standards for all regulatory submissions.

Serve as FDA contact for responsible projects and foster positive and effective working relationships between project team members and health authority reviewers

Interpret and advise the project team on the application of industry regulations‚ the FDA review process and ex-US regulatory requirements.

Coordinate and consult with other departments on the content‚ review and assembly of regulatory documentation.

Manage regulatory project plans and timelines for projects in accordance with project‚ department and corporate goals.

Education

  • A Bachelor‚ Masters‚ PharmD or PhD degree in a scientific discipline is required.

Skills

  • A minimum of 10 years experience in the regulatory affairs (or related role) in the pharmaceutical industry.
  • Experience with both US and ex-US regulatory filings.
  • Experience in organizing and running successful FDA meetings.
  • Experience with multiple regulatory disciplines (CMC‚ clinical‚ labeling, etc.).
  • Excellent oral and written communication skills.
  • Demonstrated understanding of regulations and guidelines governing drug development (particularly clinical drug development) including ability to apply these to overall strategic drug development.
  • Develops and implements policies in compliance (cGMP and GLP) and management of quality systems; ensure compliance with SOPs.
  • Demonstrated leadership ability in team/department settings.