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Director of Regulatory Affairs

Reference Number: 3020
Location: Remote

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

The Director of Regulatory Affairs is responsible for leading the day-to-day activities of Global Regulatory Affairs.  This role is a generalist strategic global role and will oversee the regulatory aspects of a number of activities including several global clinical trials, CMC regulatory, and nonclinical regulatory development.  The candidate will have strong strategic leadership skills and will have a strong understanding of regional (US and EU) and overall drug development processes and strategies with direct experience.  The person in this position will have the opportunity to lead large global submissions (INDs, NDA’s, MAA’s) in the US and EU and other regions and will co-lead regulatory interactions such as face-to-face meetings with global regulators.  This role will also oversee global submissions management and will report directly to the Vice President of Global Regulatory Affairs.

Major tasks and responsibilities will include:

  • Leads and develops a regional and/or global regulatory strategy that is reflective of applicable US, EU and other regional requirements.
  • Leads the strategic aspects of the global dossier and core prescribing information.
  • Conducts regulatory risk planning and mitigation and can generate flexible regulatory strategic options and shift readily.
  • Leads the development and implementation of innovative strategies to maximize the likelihood of regulatory success.
  • Experience leading regulatory interactions in a global arena (especially USA, EU).
  • Oversees an Operations Submission Manager who will manage the preparation, timelines, submission, distribution and archives of all types of submissions -- globally -- with an understanding of global submission requirements, standards and processes.
  • Working directly with CRO’s with oversight of contracted and transferred regulatory aspects.

We seek candidates with the following qualifications:

  • Bachelor's degree in scientific discipline; advanced degree preferred.
  • At least 8 years of previous industry experience in Regulatory Strategy in the USA and EU with diverse experience on leading and developing the strategy for multiple submission types including large submissions with intimate knowledge of the Common Technical Document.
  • Experience in the Metabolic and Cardiovascular Therapeutic Area is preferred.
  • Some scientific knowledge in chemistry, general biological/physical science and the ability to apply that knowledge to regulatory preferred.
  • Proven expertise in leading face-to-face regulatory interactions.
  • Strong Regulatory writer and reviewer for key documents such as meeting requests, briefing documents, Module 2, Module 1 documents.
  • Ability to lead, drive, communicate effectively, establish and maintain productive working relationships, and influence peers and others within the organization.
  • Proven ability to creatively solve strategic challenges posed by large, complex submissions.
  • Recent experience with large complex submissions NDA’s is preferred.
  • Strong organizational skills and high level of attention to detail, with the ability to coordinate multiple large and diverse projects simultaneously.
  • Excellent written and verbal communication skills with the ability to meet regulatory requirements.
  • Ability to be highly driven and self-sufficient.
  • Ability to wear multiple hats and work in a small company and virtual company fast-paced environment.
  • High integrity with respect to maintenance of proprietary, confidential information.
  • Strong decision-making and problem-solving skills.

 

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 3020. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.