Senior Regulatory Affairs Specialist

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Senior Regulatory Affairs Specialist

  • Location:

    Kent

  • Sector:

    Consumer Goods

  • Job type:

    Permanent

  • Salary:

    £0 - £0

  • Job ref:

    TM1435

  • Published:

    2 months ago

  • Expiry date:

    2022-05-28

Alexander Steele has partnered with a leading global FMCG and Health consumer goods business that has an exciting and challenging opportunity for a Senior Regulatory Affairs Specialist to obtain and maintain market authorization for their Medicinal products as well as other personal care products and corporate projects as assigned. You will be responsible for delivering regulatory guidance and support from concept to launch; interpreting and applying all relevant regulations, guidelines and UK legislation and acting as liaison between the Company and Health Authorities Key responsibilities: • Obtain and maintain market authorisation for company products, with emphasis on Medicinal products. • Represent Regulatory Affairs in project team meetings and provide regulatory guidance and perspective to team members in determining appropriate actions to meet launch timelines and/or to resolve technical issues. • Providing senior regulatory support to product development teams throughout the new product development process, including analysis of applicable standards, risk assessment and effective implementation of regulatory plans. • Provide UK/EU regulatory guidance to the company’s design centres in other markets regarding the potential introduction of their products into UK market. • Evaluate regulatory impact of proposed changes to marketed products and communicates clear actions to maintain product registrations and certifications. Candidate requirements: • A relevant degree in a related field • Strong Regulatory Affairs experience working with Medicinal/Pharmaceutical products; knowledge or experience in other category regulations such as medical devices, cosmetics and personal care products will be a significant plus. • Good knowledge of the EU and UK post-Brexit legislation • Cross-functional experience with the ability to build excellent relationships with internal stakeholders including R&D and Marketing to ensure products meet the regulatory requirements for the market. • Working knowledge of the regulations used within consumer products, food supplements, household products, medical devices, and pharmaceutical industries ISO 22716/ISO 13485/EU GMP) Competitive Salary Package including a performance-based Bonus, Pension and Healthcare schemes Hybrid remote working option, with travel to the site in Kent 2 to 3 days a week
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