US Regulatory Affairs Director

This global pharmaceutical and services company has multiple commercial products while also providing managed access of unlicensed medicines to patients in need.  They are expanding their operations in the United States and they are seeking a Regulatory Affairs Director who can manage all US regulatory strategies and activities in the US.  You will provide due diligence for new product acquisitions while also supporting maintenance of existing products in the US.  In addition, you will work directly with pharmaceutical partners to secure compliant access of medicines to patients with high unmet medical needs.  This is an exciting opportunity to build out the US regulatory function and make a big impact on the organization.  This company offers competitive compensation, an excellent benefits package, and the opportunity to work from home.

Responsibilities: 

  • Establish and oversee the US regulatory affairs function for the organization, including the creation of SOPs.
  • Provide regulatory expertise and due diligence for new product acquisition and new product development in the US.
  • Support maintenance of existing products in the US.
  • Provide regulatory support for designated Managed Access programs.
  • Prepare applications for marketing authorizations in new territories, maintenance of existing licenses, variations to existing licenses, transfer of licenses, etc.
  • Development of regulatory strategies and provision of regulatory advice internally.
  • Interface directly with health authorities, CRO support, and pharmaceutical client partners.
  • Ensure proper filing of regulatory submissions and correspondence either internally or via external contractors.
  • Ensure that all regulatory activities comply with current Regulatory Agency requirements and guidelines.
  • Assist in establishing and maintaining a Regulatory Intelligence repository. Ensure that Regulatory Intelligence updates are effectively communicated within the company.

Knowledge and Skills:

  • BS degree in life sciences or related scientific discipline. Advanced degree (MS, PhD, PharmD) preferred.
  • At least eight years of industry experience with six or more years in Regulatory Affairs for pharmaceuticals.
  • Broad experience across all aspects of Regulatory Affairs including clinical regulatory strategy, regulatory CMC, and commercial regulatory affairs.
  • Solid knowledge of FDA and ICH guidelines and regulations for pharmaceuticals.
  • Experience working directly with US health authorities.
  • Strong knowledge of CTD and eCTD structure and excellent regulatory writing skills.
  • Prior client-facing experience working at a CRO or Regulatory Consulting company highly desired.
  • Excellent organizational and project management skills.
  • Outstanding written, verbal and interpersonal communications skills.
  • Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment.
  • Ability to work independently with minimal oversight.

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