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Interim Head of Scientific regulatory affairs

Physics Road, Nerudia Liverpool, England, United Kingdom, L24 9HP

Interim Head of Scientific regulatory affairs

  • NE02326
  • Physics Road, Nerudia Liverpool, England, United Kingdom, L24 9HP

About Us

We're a truly international company, fourth largest in our industry and operating across 120 markets. An inclusive, innovative global FMCG business supported by over 27,500 employees. As we embrace a new era of growth, we are transforming. Our ways of working and culture are driven by a challenger mindset, constantly questioning the status quo. Our agility and entrepreneurial spirit, alongside award winning development programmes, enable innovation and success while creating exciting and rewarding career choices.

As we move forward, our customers will be at the heart of what we do, evolving to needs and expectations and committing to a more meaningful contribution to harm reduction by building a successful NGP business. Integral to our long-term success is our sustainability strategy, behaving responsibly and supporting our ambitions, all underpinned by high governance.

Encouraging inclusion at local levels and supporting a developing and robust diversity agenda globally, we’re fully committed to creating and maintaining an environment that celebrates and respects difference.

The Role

To lead the development & delivery of regulatory submissions for IMB’s Combustible business globally (ex US) and NGP globally to enable legal manufacture, marketing, and sale of all products.  Ensures that all legal obligations with respect to product reporting to, and pre-market approval by, regulators in line with category commercial plans are met. Meets post-market obligations and robustly defends products with regulators.

 

Key Accountabilities

 

·        Lead substantive programmes that deliver PMTAs that demonstrate to the US FDA that our EVP products are ‘appropriate for the protection of public health’

·        Creates PMTA dossiers ensuring all data points are framed and aligned with the narrative of protecting US public health, and that our scientific assessment shows that our NGPs are appropriate for the protection of US public health

·        Lead the service that ensures all pre-market notification requirements in the EU are met for NGP & combustibles enabling manufacture and sale in line with commercial plans

·        Lead the development & delivery of scientific dossiers for NGP where product approval is required by regulators prior to launch

·        Ensure that all post-market reporting requirements to regulators are met on an ongoing basis

·        Provide proactive and expeditious support to the Group in the event of alleged product non-compliance and raise early concern of foreseen compliance issues that could impact current or future product development and launches.

Skills & Experience

Essential

 

  • Strong project and programme management experience
  • Demonstrated experience (at least 5 years) in a highly regulated product category, with a knowledge and passion for science, technology, and regulatory affairs
  • Demonstrated experience in delivering scientific & regulatory dossiers to authorities, with a track-record of product approval, where commercial stakes are high.
  • Strategic perspective, able to assess and relate impacts of regulatory trends and initiatives on our business over short and long term
  • Understanding of the primary drivers of tobacco regulation at a global and local level
  • Skills in developing and executing appropriate scientific and technical regulatory engagement strategy, activities and key messages in co-ordination with other departments
  • Ability to analyse complex and detailed scientific and technical issues
  • Strong interpersonal skills along with an ability to build and leverage strong and meaningful working relationships internally and externally across a diverse stakeholder network
  • Exceptional written and verbal communication skills
  • Team manager/leadership experience; effective team leader able to bring the best out of the wider team
  • Self-starter who truly enjoys working in a fast-paced, innovative environment

 

Desirable

 

  • Experience in engaging externally with influential stakeholders

Interested?

Interested applicants should apply with their CV highlighting their suitability for the role.

Apply Now

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1901

The year Imperial was founded through the
coming together of 13 UK family-run
businesses

33,000

Imperial employees worldwide

160

Number of markets worldwide in which our products are sold