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Regulatory Writer (Science)

Bewerbungsschluss: 15.12.2021

Standort: UK, Großbritannien

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

We are currently recruiting for a Regulatory (Science) Writer to join our exciting new Scientific Regulatory Affairs team. The role could be located in either our Bristol or Liverpool office, with travel required from time to time to the office you are not based at.

As a Regulatory Writer, it would be your responsibility to prepare scientifically substantiated dossiers, including forming the narrative and interpreting our scientific data, for submission to regulatory authorities. This role is key in securing regulatory outcomes for our commercial choices and enabling Imperial Brands (IMB) to protect & defend its products globally.

Key accountabilities

  • Write comprehensive, thorough & well-structured narratives with impactful storytelling underpinned by IMB’s tobacco harm reduction strategy. Thus, ensuring submission to regulatory authorities to secure regulatory outcomes for our commercial choices, such as Pre Market Tobacco Applications in the US,
  • Respond to requests from the regulatory agencies, such as within Deficiency Letters, via the production of documents clarifying any points highlighted, and providing additional information and/ or supporting data, under significant time pressure.
  • Possess comprehensive understanding of product categories and regulations and keep informed on regulatory/ scientific developments relating to the product portfolio; address any societal/regulatory concerns as part of the narrative.
  • Maintain and use the Regulatory Information Management System (RIMS) (for building dossiers).
  • Work in close collaboration with the Harm Reduction & Engagement team to define research needs and support the development of a scientific publication strategy · Work in close collaboration with technical subject matter experts (e.g., toxicologists, clinical scientists, product characterisation scientists , perception, and behavioural scientists) to gather, organise and compile information for regulatory submission.
  • Develop and maintain technical capability, via training and best practice implementation

Skills & experience

Essential

  • Educated to degree level, or equivalent, in a scientific discipline
  • Experience in regulatory writing, in a relevant industry sector or subject area · Extensive knowledge of next generation nicotine delivery products, nicotine and tobacco science and public health issues
  • Excellent attention to detail
  • Clarity of thinking in structuring documents so that they present complex information in a logical manner
  • A proven ability to meet deadlines, and under significant time pressure
  • Can operate effectively in a collaborative and directive business environment and able to develop broad, cooperative relationships with a set of diverse stakeholders
  • Self-motivated, independent and proactive
  • Excellent oral and written communication and interpersonal skills


Desirable

  • Medical writer qualification
  • Proven experience authoring Regulatory documents (CTDs, NDAs, MAAs, CERs, CSRs)

What we offer

Imperial Brands offers a competitive package of salary, bonus scheme, pension and 25 days holiday (with an additional 4 days on top to cover the Christmas period and bank holidays).

Next steps

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

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