Regulatory Affairs Senior Manager (or) Associate Director

Regulatory Affairs Senior Manager (or) Associate Director

My client is a commercial-stage biopharmaceutical company focused on the discovery and development of treatments for rare pediatric diseases.  With a major recent approval and six development programs, they are in a prime position for growth over the next five years. This company is looking for a Senior Manager/Associate Director Regulatory Affairs professional to lead Global and ROW filings. You will report directly to the Executive Director of Regulatory Affairs, participating in interactions with the FDA and other regulatory agencies, and leading cross-functional sub teams. The ideal match will thrive in a company where the pace is fast and ambiguity is a regular day at the office.

 

Responsibilities:

  • Preparation and submission of INDs, CTAs, amendments, reports and correspondence to regulatory agencies for assigned projects
  • Facilitate and implement integration of multidisciplinary regulatory programs into the project team development plans for all assigned projects
  • Assist in the planning, preparation and conduct of meetings with regulatory agencies as appropriate
  • Initiate and prepare regulatory agency correspondence (telephone, written, meetings, etc.) to facilitate expedient and efficient product development and registration of assigned products
  • Research and assess current and proposed regulatory, scientific and pertinent topics (i.e., external meetings, workshops and conferences)
  • Review all documents to be submitted to regulatory agencies to ensure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance, and are presented in a way that facilitates agency review
  • Guide project teams to implement regulatory strategies and provide regulatory support for product development and registration of assigned products

 

Knowledge and Skills:

  • A./B.S. in the natural sciences or health related field is required
  • Minimum of 5 years’ hands-on regulatory affairs and submissions experience
  • Must have managed or driven filling process for IND’s, CTA’s and/or marketing applications
  • Self-motivated with the ability to work with uncertainty and make good judgments independently
  • Experience working successfully with cross functional teams
  • Ex-US experience a plus
  • Orphan drug experience is also a plus

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