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EST 1985
Serving classified ads since 1985.
Serving classified ads since 1985.
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Vice President, Regulatory Affairs

Description

We're looking for a candidate to this position in an exciting company.

  • Provides guidance and leadership to the members of the regulatory affairs teams.
  • Directing all regulatory activities as well as developing necessary SOPs
  • Develops global regulatory plans and strategies that support client's investigational and to-be marketed products
  • Develop and implement strategies for the timely preparation and execution of submissions to regulatory authorities for all phases of the product life cycle.
  • Provide expert analysis of regulatory information and is able to properly communicate with C-Suite and other stakeholders
  • Analyze and make recommendations for improving internal and vendor compliance with the FDA and international regulatory authorities as well as ICH quality regulations and guidelines.
  • Communicate with US and other international regulatory agencies; ensures the company is compliant with US and international regulatory requirements
  • Develop and maintain current regulatory knowledge and ensure that staff is aware of new and existing relevant procedures
  • Prepare/oversee the preparation of meeting requests, briefing documents, coordinate and prepare team for meetings, and interface with regulatory authorities, be primary liaison with regulatory authorities for day-to-day interactions.
  • Coordinate and prepare responses to requests for information from regulatory authorities
  • Develop and manage a global budget supporting regulatory department
  • Hire, mentor, and support the personal and professional development of regulatory staff
  • Minimum of 10 years of drug development regulatory experience
  • PhD preferred; or science based degrees
  • History of successful interactions with regulatory HAs (FDA/EMA), 
  • NDA and MAA experience, IND and CTA experience with small molecules.
  • Experience developing early and late-phase oncology products
  • Knowledgeable of US, EU and international regulatory affairs, GXP compliance and associated regulations.
  • Must have experience in the preparation and submission of regulatory documents (IND/CTA/NDA/MAA)
  • Knowledge and understanding of global regulations and guidelines
  • Proven management and leadership experience, including identification and development of talent.

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Boston, Boston, England, Lincolnshire, PE21, United Kingdom

  • Ad ID:  14909690
  • Ad Type:  Offered
  • Posted on:  05/07/2020, 02:54
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