Regulatory Affairs Manager - Biocides

Rb Uk Commercial Ltd ,
Slough, Berkshire
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Overview

· Working collaboratively with the relevant Global and country teams to establish and implement the regulatory strategies within agreed timescales to bring competitive advantage to RB brands. · Management of all regulatory and development projects relevant to the UK brands. Manage/ oversee regulatory strategies and the preparation of regulatory documents targeted at the UK Market. · Monitoring, collecting, interpreting and applying all relevant legislation, regulatory issues & trends and regulatory guidelines in the UK and keep the UK business up to date on national regulatory trends, risks and opportunities. Providing advice to the business on regulatory issues as necessary and assist in developing of strategies and plans of action to address them. · Assisting the quality function in maintaining compliance with registered details · Interfacing with relevant government agencies (e.g. MHRA), industry associations (PAGB and ABPI) and key opinion leaders to assess the impact and implementation required with all regulations, laws and industry policies that affect the ingredients, packaging, marketing, advertising, labelling and production of our products. RESPONSIBILITIES / ACCOUNTABILITIES · Management of Regulatory operations in the countries: · 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. · Interprets and applies all relevant legislation and regulatory guidelines in the UK and keeps RB local operating company up to date on national regulatory trends, risks and opportunities for the business. · Oversees regulatory approval procedure for promotional material. · Close collaboration with other regulatory, medical and quality functional groups in RB centre to ensure the UK business operates in line with strategy and that global strategy takes into account UK peculiar requirements. · Assist quality function in maintaining compliance with registered details. · Monitor, collect and interpret regulatory issues and trends that will impact RB 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. · External Affairs: · 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 with all regulations, laws and industry policies that affect the ingredients, packaging, marketing, advertising, labelling and production of our products. · Interface and represent company interests with relevant government agencies, industry associations and/or other organizations. · Advice / Training: · Provide advice and training on regulatory compliance and registration processes and requirements to the local business. · Prepare or oversee training materials for internal training (e.g., for sales, marketing and customer service personnel) and conduct training sessions on relevant scientific, regulatory and safety issues. · Audits / Continuous Improvement: · 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 organization of internal audits and monitor audits performed by 3 rd parties. · Assist the Regulatory Affairs Director in conducting internal audits to ensure regulatory and safety compliance. KNOWLEDGE AND EXPERIENCE · Graduate calibre, with regulatory and product safety experience within an FMCG company · Thorough understanding of the current regulations, laws and industry requirements. · 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 · Competent with PC tools and information systems · 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. This job was originally posted as www.totaljobs.com/job/89907256

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