Regulatory Intelligence Project Manager
Abbott
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.
Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs around 6,000 people across ten sites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford, Kilkenny and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
Abbott Ireland Nutrition Division Cootehill Cavan
Abbott Nutrition produces a range of infant formulae in all pack sizes under the brand name “Similac”. To complement the range of “Similac” infant formulae, the facility also manufactures a range of follow on formulae under the brand name of “Gain”. The essential ingredient is liquid skim milk and this is combined with carbohydrate, vegetable oils, vitamins and minerals. The product is blended, pasteurised, dried and packaged at the site and once packaged, is distributed to Europe, South East Asia, the Middle East, Latin America and Canada.
Established in 1975, Abbott Nutrition in Ireland is the largest powder manufacturing facility for the production of infant formulae within the Abbott Corporation worldwide. Approximately 1,000 dairy farms in Ireland and Northern Ireland supply quality milk to the Cootehill facility which processes 500,000 litres per day. This secure supply together with Ireland’s reputation as a green, clean environment is of significant strategic importance to Abbott Nutrition.
The Opportunity
Our location in Ireland, currently has an opportunity for Regulatory Intelligence Project Manager, specifically supporting the Abbott Nutrition EMEA region.
This position will manage compliance related activities and assessments linked to new regulation or changes to existing regulations and lead multiple associated medium to large-scale projects that support Abbott Nutrition’s Regulatory Affairs strategic and compliance objectives.
This regional position will independently interface with Abbott affiliates, AN Division, AN manufacturing plants, R&D, Quality, Supply Chain and others. Success will depend on leadership in managing the process, governance and resources required to timely assess market signals that impact the Abbott Nutrition business. The position will achieve the objectives through effective communication, and strong interpersonal and presentation skills.
WHAT YOU’LL DO
Lead regional regulatory intelligence operations, coordinate with EMEA Commercial Affiliates to monitor and assess impact to approved and draft regulations/standards, including commodity and horizontal legislation
Ensure timely tracking and update of draft regulations/standards in relevant platforms and SharePoint
Interact with other Regulatory departments and functions to ensure consistent assessment of impact and reporting
Represent relevant region as regulatory subject matter expert for regulation impact to AN business. Responsible for identifying and managing critical emerging regulations, and timely communication to senior leadership.
Provide clear and consistent communication, both oral and written to all project stakeholders on key project elements such as scope timeline, issues, etc.
Support cross-functional project timelines and follow up with project team members to ensure timely completion of tasks.
Recommend changes to policies, procedures and systems that will ensure AN and market compliance requirements are met.
Recommend and implement strategies and enhancements to improve efficiency.
Accountability/Scope
The compliance of AN products is a competitive advantage in the marketplace, and any lessening of our standards or not meeting market requirements can have an adverse long-term impact on our business. This position will work with limited supervision.
Education and experience you will bring:
Required
Bachelor’s degree in a relevant discipline/or equivalent work experience is required (Chemistry, Microbiology, Food Science, Engineering, Business Administration).
5-7 years in a regulated nutritional food-manufacturing environment, preferably pediatric or medical nutrition products, in a Regulatory, Quality, R&D, Project Management, Procurement or Operations function and good knowledge of food and nutrition regulations.
3-5 years’ experience in project roles.
Critical thinking/problem-solving skills.
Ability to plan and facilitate meetings.
Effective Stakeholder Management.
Preferred
Master’s degree
Ingredient expertise, process expertise, and formulation expertise in nutritional and infant concepts.
Well-developed interpersonal, communication and negotiation skills.
Continuous improvement methods and application (for example: Lean, Six Sigma, Class A, etc.).
Change management.
Sound decision-making skills contributing to high levels of competence, confidence and credibility are required.
Cross-functional/cross-divisional experiences.
Connect with us at www.abbott.com or https://www.ie.abbott/, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.