Regulatory Affairs Manager

Ref. no.: MK/41220

Tags: Regulatory Affairs

Location(s): Limerick Tipperary

Salary range (€): Negotiable

Additional benefits:

Minimum experience required: 5 - 6 Years

Employment type: Permanent Full-time

Minimum qualification: Third Level Degree

Contact person: Michelle Kilcar

Contact e-mail: michelle@ccprecruit.ie

Job description:  

Regulatory Affairs Manager

Purpose of position:

Manage, control and communicate necessary information with respect to master formula and required support systems, to consistently manufacture product that complies fully with regulatory requirements in individual markets.

Principle Accountabilities:

• Manage, assess and communicate accurate information on current and evolving regulatory requirements to relevant management.
• Provide direct assistance with the registration of new and existing products in markets supplied by the plant.
• Liaise, communicate and participate actively with regulatory agency to ensure ongoing plant compliance. Manage and co-ordinate plant regulatory inspections.
• Participate in National/International industry and trade association meetings to represent the company's interests.
• Manage, verify, control and communicate necessary information with respect to master formulae information and support documentation to consistently manufacture products that comply fully with regulatory requirements in individual markets.
• Manage and implement appropriate surveillance mechanisms to protect WNI interests.
• Lead, facilitate or support, as appropriate, cross-functional teams dedicated to establish harmonised solutions for quality projects within the business.
• Lead and manage the implementation of Quality/Regulatory projects within the business ensuring achievement of key deliverables on time and within budget while adopting best practices within the organisation.
• Support the Quality Manger (WNI) by providing background, system knowledge and technical input as required.
• Work with and support other departments, as required, to develop sustainable sustainable solutions to recurring issues.
• Lead, manage and develop the Regulatory Affairs team in WNI people skills to ensure business and people objectives are met.
• Management of the DMS to control cGMP related documentation for the site.

Knowledge / Experience / Skills Needed:

• A Science graduate, preferably holding a postgraduate qualification, with a minimum of 10 years relevant industry experience, or equivalent.
• Strong interpersonal skills with at least 5 years management experience, preferably in a regulated environment.
• A contemporary knowledge of food law, EU regulatory systems and industry standards.
• The ability to define, plan and manage project workstreams, resources and all realated budgets, to ensure that project work undertaken is delivered fit or purpose, to agreed deadlines and within budget.
• Highly motivated with the ability to work under pressure and meet tight deadlines.
• Capability to interact in a highly professional manner with all appropriate regulatory bodies.

For further information please contact Michelle Kilcar at CCP Recruitment on 091 730022 or email michelle@ccprecruit.ie

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