An opportunity within Senior Regulatory Affairs has become available with a global manufacturing organisation and key employer, within the area.

Package Highlights:

• A competitive base salary available according to level of experience
• The beauty with this position is that it is also offering extremely attractive hybrid working:  40:40:20, ie. 2-3 days in the office and the remainder working from home, so an improved work/life balance available!
• 37 hours per week Monday to Friday only
• 9% matched pension contribution
• All employee bonus scheme
• Life Assurance cover at 4 x base salary
• HealthShield Medical/Health cover

The Must Haves:

Our client is only considering individuals with a medicinal products or closely associated background.

Qualifications/Knowledge/Training/Experience required for the role:

• Ideally a degree in a related field
• Strong working knowledge of the medicinal products regulations
• An additional advantage would be knowledge and experience in other category regulations (ie. medical devices, cosmetic, food supplements, detergent and/or general consumer products)
• Good knowledge of the EU and UK post-Brexit legislation
• Wok experience in a plant-based manufacturing environment
• Knowledge of ISO, BRC ad IFS based quality management systems and their application
• Excellent influence, persuasion, verbal and written communication skills.

Position Highlights:

You will be responsible for delivering regulatory guidance and support from concept to launch.

• This position will interpret and apply all relevant regulations, guidelines and UK Legislation and act as liaison between the Company and Health Authorities.
• The role holder will be responsible for 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.

Specialist 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.
• Provide UK/EU regulatory guidance to company design centres in other markets regarding the potential introduction of their products into UK market.
• Host and support Technical Dossier external regulatory audits or inspections.
• Act as a regulatory contact to the competent authorities for medicinal products sold in UK and EU for which their associate company in the US is the legal manufacturer. Support other products as assigned.
• Evaluate regulatory impact of proposed changes to marketed products and communicates clear actions to maintain product registrations and certifications.
• Monitor and communicate regulatory intelligence to assist in the development of business and compliance plans.
• Anticipate regulatory obstacles and emerging issues during the product lifecycle and develop solutions.
• Assist in the creation, development and implementation of departmental SOPs.
• Independently manage multiple projects, department initiatives and day-to-day tasks.

If you have the must have experience, want to join a forward thinking organisation where you can make a difference and at the same time enjoy an improved work/life balance with the attractive hybrid working availability, then we would very much like to hear from you.

Please email your CV in the first instance, ensuring it is completely up to date in order to be correctly evaluated.

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