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EU Regional Regulatory Affairs Director – based in the UK or Europe
Competitive Salary + Benefits
About blu (UK)
It’s an exciting time to join blu (UK). The world’s biggest e-cigarette brand has just launched in the UK, we’ve hit the ground running with 20,000 stockists and we have big plans for the future. To do this we need an experienced Regulatory Affairs Director for the UK and Europe.
About the job
You’ll represent the companies positions before governing and political bodies, regional authorities, regulators and other organisations. Your advice will help influence the compliance, regulation and safe use of the blu e-cigarette product portfolio in the UK and Europe.
You’ll inform and educate key internal and external stakeholders on regulatory matter,s too. This will influence the strategic and commercial decisions we make about our product portfolio.
In return, you’ll get a competitive salary, generous holidays, a bonus scheme, healthcare and death-in-service. More benefits, like pensions, are coming soon.
In this newly created role with blu UK, you’ll:
- Advocate the company’s regulatory positions to regulators, key accounts, distributors, media and trade organisations
- Implement parent company compliance policies to UK/EU affiliates
- Direct premarket notification and/or licensing processes before the appropriate domestic and EU bodies, which may include the Medicines and Healthcare Products Regulatory Agency (MHRA)
- Monitor and report on global regulatory developments and their potential business impact on the e-cigarette category
- Interact with regional trade organisations and industry groups to identify regulatory trends and policies that could affect the e-cigarette business in Europe
- Direct all regional regulatory submissions including, but not limited to: e-cigarette notifications, ingredient reporting, premarket licenses, post-market surveillance
- Reporting to the Director, Regulatory Affairs and Associate, General Counsel at our parent company, Lorillard, Inc. in the USA, you will support her in creating and implementing policies, standards and procedures to comply with local regulations.
Experience and Knowledge Required:
With over significant post-qualified experience, you’ll have:
- A wealth of legal or regulatory experience gained as legal/regulatory counsel within a pharmaceutical, biotech / life science company or in a life science division of a law firm
- Strong knowledge of EU law
- Exceptional academic credentials including Bachelor of Law (LLB) and a relevant business postgraduate Masters
- Bar qualification in one or more EU jurisdiction
- Experience working on new drug projects or new product developments
- Respect as an influencer within governments, regulatory and legal communities
- Previous exposure to complex legal matters relating to new drug entities and market entries
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