Full Time

Vice President, Regulatory Affairs

Posted 3 weeks ago
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Job Description

Vice President of Regulatory Affairs – Remote – United States

Global Life Science Hub are partnered with an exhilarating digital health organisation that are utilizing an astonishing and complex AI tool that will allow hospitals and clinics to rapidly locate the hardening of the arteries to prevent cardiac arrest.

Having just closed out on a recent $300 million in funding, this will allow the company to rapidly market their product into hospitals and clinics worldwide. With their software, clinicians are able to identify the risk of a heart attack 90% quicker than normal making this an incredibly lifesaving product.

Responsibilities:

  • Define the future vision and implement strategies in close alignment with internal innovation initiatives
  • Lead all aspects of submission publishing and archiving activities globally associated with generating highly complex electronic submissions within Global Regulatory Operations
  • Provide cross-functional leadership for complex global filings and work collaboratively with external functions
  • Provide decision support to the wider business in relation to new and proposed regulations/changes and how they impact on regulatory road maps and strategy planning
  • Identify opportunities to further advance outsourcing strategies to leverage efficiencies in operations and provide more bandwidth to address the growing business needs for marketed products and development programs across the regions
  • Develop deep strategic relationships with vendors and lead governance meetings
  • Responsible for planning of resources, forecasting and budgeting
  • Ensure the company follows all regulatory technical guidance requirements for all submissions globally

Experience/Qualifications:

  • A bachelor in a life science sector at a minimum
  • 10 years Regulatory Affairs experience
  • Strong IND and NDA submissions
  • Extensive FDA experience
  • 501k experience is highly advantageous

Apply:

The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.

If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com

GLS Hub