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 over 5,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford 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.

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® – to help get the nutrients they need to live their healthiest life.

Abbott Ireland Commercial Liffey Valley Dublin Opened in 1946, this operation, based in Liffey Valley Dublin was the first Abbott business unit to be established in Ireland. This business is responsible for the sales, marketing and distribution of a wide range of diabetes, diagnostic, and nutritional products in Ireland.

Primary Function of the role

• Provide support for the regulatory department to ensure efficient and compliant business processes and environment.
• Execute regulatory tasks and exercise influence generally at the middle management level.
• Maintain current registrations by preparing documentation required and submitting documentation on schedule as directed.

Responsibilities

• Ensures timely approval of Nutritional products, functional foods & drugs for EURI region. Possess well developed skills in directing development of product registration dossiers, submission, progress reports, deficiencies, amendments, etc.
• Provide regulatory input to product lifecycle planning.
• Lead regulatory submissions strategy and update strategy based upon regulatory changes.
• Interpret and apply regulatory requirements.
• Understand, investigate and evaluate regulatory history/background of product context in order to assess regulatory implications for approval.
• Understand the business environment and relate extensive knowledge of internal and external activities to trends; determine trade issues to anticipate regulatory obstacles.
• Participate in risk-benefit analysis for regulatory compliance.
• Plan and organize project assignments of substantial variety and complexity; initiate and/or maintain schedule for projects and project milestones.
• Maintain regulatory data in electronic systems.
• Depending on specific role, the Regulatory Affairs Specialist may be involved in various regulatory activities (review of product documentation; regulatory submissions and follow-up; evaluation of product and manufacturing changes for regulatory implications; maintaining annual licenses, registrations, listings and patent information; review and approval of label changes, advertising and promotional items; provide regulatory input to product safety issues and product recalls, etc.)
• Partners with affiliates to support regulatory agency interactions to expedite approval of pending registration.
• Participates/ Awareness on Affiliates Business plans, project plan, regulatory submission strategy, any risks management.
• Advises project teams on manufacturing changes, line extensions, technical labelling, appropriate regulations and interpretations.
• Partner with other regulatory functions for smooth project transition and launch.
• Submit and review change controls to determine the level of change and consequent submission requirements.
• Assist in SOP development and review.
• May provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
• Participate in the development of less experienced staff by setting an example, providing guidance, and offering counsel.
• Influence middle management on technical or business solutions.
• Perform work under minimal supervision and may independently determine and develop approach to solutions.

Minimum Requirements

• Bachelor's degree (or equivalent) is required - preferred area of focus in science (biology, chemistry, nutrition, dietetics, microbiology, immunology, medical technology, pharmacy, and pharmacology), math, engineering, or medical fields. M.S. in a technical area is preferred. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• 2-3 years of experience in regulatory preferred, but may consider quality assurance, research and development, scientific affairs, operations, or related area.
• 3-4 years of experience in a regulated industry (e.g., nutritionals, medical products).
• Regulatory knowledge of (as applicable - note: This knowledge may be developed through tenure in this position.):
  • a. Regulatory requirements, guidelines, policies, standards, practices, history, ethics, agency structure and processes, etc.
  • b. GxPs (GMPs, GLPs, GCPs).
  • c. Principles and requirements of promotion, advertising and labelling.
  • Experience/ keen desire to utilise RIMS (systems) for submission dossiers management
  • Experience in stakeholder management specifically with manufacturing sites.
• Strong Communications skills
• Follow scientific arguments, identify regulatory scientific data needs and, with supervision, solve regulatory issues and define regulatory strategy.
• Evaluate various technical alternatives.
• Strong attention to detail.

Accountability/Scope:

• Execute and manage technical and scientific regulatory activities.
• Participates in conflict resolution at the team level.
• Function independently as a decision-maker on regulatory issues and assure that deadlines are met.
• May lead a cross-functional project team.