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Senior Director Regulatory Affairs

Reference Number: 3254
Location: NY

Our client is a specialty pharmaceutical company.  They have asked us to assist them in their search for a Senior Director of Regulatory Affairs.

Major tasks and responsibilities will include:

  • Provides leadership to the Regulatory Affairs team of professionals, establishes annual goals for the group, and works with team members to achieve those goals.
  • Responsible for the budget for Regulatory Affairs.
  • Responsible for employee recruiting, training and retention for the RA department.
  • Ensures the effective management of agreements (e.g. Confidential Disclosure Agreements, Requests for  Proposal, Consulting Agreements, Master Services Agreements, etc.) for Regulatory Affairs.
  • Reviews agreements (e.g. Master Services Agreements with CROs, CMOs, CTOs; Clinical Trial Agreements; etc.) for Regulatory Affairs and inputs required for the execution of the agreement.
  • Works with direct reports and contractors to determine and communicate program/project-related regulatory requirements to program/project team members and partners.
  • Provide regulatory strategies are issued and maintained for all company projects.
  • Works with direct reports, contractors and program/project team directors to establish work plans related to regulatory submissions.
  • Ensures the on-time compilation, review and submission of regulatory dossiers in collaboration and cooperation with functional units, program/project team members, partners, vendors and others.
  • Tracks KPI’s for departmental objectives and report out on a monthly basis.
  • Oversees and supports technical and scientific regulatory activities including: Discovery and Translational Research, Technology Transfer, Process and Method Development, Manufacturing,Pre-Clinical Safety, Clinical, Safety and Immunology.
  • Ensures the development of and document regulatory strategies to ensure the success of development programs and projects at all stages of the regulatory process.
  • Ensures that all regulatory submissions comply with scientific, regulatory and Company standards, and are written and formatted in a consistent manner.
  • Ensures that on-time submission of all routine regulatory submissions (e.g. Ongoing Stability Data, Updates to Investigator Brochures, Annual Reports to Regulatory Agencies, Ethics Committees, etc.)
  • Provides guidance to functional units to resolve variances (e.g. Stability Failures, Clinical Holds, etc.)
  • Acts as a liaison to Regulatory Agencies.
  • Keeps abreast of changes to global regulations and provides staff training on current and new regulatory requirements.
  • Maintains professional development plans for all direct reports and staff. 
  • Participates in professional associations, industry groups, etc.

We seek candidates with the following qualifications:

  • Must have a Bachelor’s degree in a life science related subject.
  • Master’s or doctoral degree preferred.
  • Experience in biologics and/or vaccines required.
  • Must have a solid understanding of the regulatory and legal frameworks, regulatory requirements, legislation, and processes and procedures related to vaccine development. 
  • Must be able to combine the scientific and technical aspects of regulatory affairs, manage projects and think critically. Requires involvement in international/multinational/global issues and lead regulatory strategic development. 
  • Knowledge of statistics a plus.
  • Must have strong project management skills and technical/scientific writing and document formatting experience.

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3254. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.