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RA Manager Biocides

Michael Page Engineering & Manufacturing
Job LocationSlough
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Opportunity to work for a truly innovative and market leading conglomerate based in Slough. This role would be part of a 26 strong regulatory team, primarily focusing on biocides.Client DetailsWorld renowned FTSE 100 business based in Slough, currently searching for a specialist Regulatory Affairs individual, with a background in BiocidesDescriptionThe key responsibilities of the RA Manager- Biocides are:

  • Management of all registration projects, in relation to Healthcare products, which are relevant to the UK Business
  • Oversees regulatory strategy and preparation of regulatory documents targeted at the UK market.
  • Oversees the submission of PSUR, Renewal, Safety variations, and/or variations to the label/leaflets as required in the UK.
  • Interpret and apply all relevant legislation and regulatory guidelines in the UK
  • Oversees regulatory approval procedure for promotional material.
  • Close collaboration with other regulatory, medical and quality functional groups to ensure the UK business operates in line with strategy
  • Assist quality function in maintaining compliance with registered details.
  • Monitor, collect and interpret regulatory issues and trends that will impact their products, policies and procedures, share this information with appropriate local and global functions and assist in the development of strategies and plans of action to address them.
  • Interface with relevant government agencies (e.g. MHRA), industry associations (PAGB and ABPI) and key opinion leaders to assess the impact and implementation of required company compliance
  • Interface and represent company interests with relevant government agencies, industry associations and/or other organisations.
  • Lead internal investigations into allegations of non-compliance of UK products and coordinate with the qualified personnel the activities necessary to expeditiously resolve local regulatory dispute; assisting in the organisation of internal audits and monitor audits performed by 3rd parties.
  • Assist the Regulatory Affairs Director in conducting internal audits to ensure regulatory and safety compliance.
    • ProfileThe ideal RA Manager- Biocides will have:
  • Graduate calibre, with regulatory and product safety experience within an FMCG company
  • Thorough understanding of the current regulations, laws and industry requirements in relation to Biocides
  • Exceptional ability to manage workload and identify priority tasks to meet tight deadlines
  • Strong influencing / communication expertise
  • Ability to build good relationships and challenge constructively and confidently
  • Ability to consolidate large volumes of complex information, interpret & construct straightforward plans. Naturally inquisitive and interested in our brands
  • Confident and capable of operating at all levels and able to resolve conflict situations
  • Ability to challenge the status quo and propose improvement.
  • Able to apply appropriate problem-solving techniques to evaluate and resolve operational issues.
  • Ability to motivate and coach people within a results-oriented culture, where personal responsibility/initiative, teamwork, and mutual respect are key.
    • Job OfferCompetitive salary and attractive benefits package

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