Senior Specialist Regulatory Affairs

Job Description:

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 114,000 colleagues serve people in more than 160 countries.

Abbott In Ireland

Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.

• WHAT YOU’LL DO
• Responsibilities:
• •    Regulatory project management for global programs (PIERs, Global Science Innovation, Supply Network, Strategic) without close supervision by manager.
• •    Lead strategic programs with supervision by manager.
• •    Develop and execute regulatory strategies to ensure successful registration and approval of international nutrition products.
• •    Represent Abbott Nutrition regulatory affairs on departmental and divisional teams, providing timely regulatory input and communication to ensure regulatory requirements are met.

•    Analyse and identify regulatory requirements against project needs.
•    Communicate registration needs before and during product development.
•    Prepare options, suggestions, and/or a regulatory assessment for product registration to achieve global project goals.
•    Execute plans, complete tasks according to priorities set by Manager, align work with business goals and align actions with agreed upon strategies.
•    Excellent verbal and written communication skills and ability to effectively present scientific data to management.
•    Assure established policies and standard interpretations of regulations are followed for assigned projects. Maintain an awareness of legislation and assess impact on Abbott business.
•    Responsible for tracking and timely completion of regulatory assignments, registration assessments, and execution of filing
•    Responsible for effective communication of regulatory requirements to project teams and internal customers (scientists, marketing, quality assurance, product development, affiliates).
•    Accountable for compliance with internal SOPs and understanding & compliance with relevant Regulations.
•    Position is highly visible to internal and external stakeholders.
 

EDUCATION AND EXPERIENCE, YOU’LL BRING
Required:
•    Bachelor’s degree is required (engineering, nutrition, chemistry or biological science is
preferred)

•    3 or more years of relevant experience (exposure to regulatory affairs is preferred)
•    Project management experience and/or exposure to project management principles.
•    High level of effective verbal and written communication skills, including ability to negotiate,
influence, and manage conflict.
•    Able to work constructively, decisively, and collegially with internal customers (scientists, marketing, quality assurance, product development, affiliates, etc.) to solve problems and communicate regulatory needs.

Preferred:
•    Master’s degree.
•    Prior regulatory experience in the food industry.
•    Knowledge of regulations relating to foods, infant formula manufacturing and/or consumer products.
•    Manufacturing/Quality/Packaging or similar experience.

Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

Job Family:

Regulatory Operations

Division:

AN Abbott Nutrition

Location:

Ireland > Cootehill : Dromore West

Additional Locations:

Work Shift:

Ie - Chsal39 (Ireland)

Travel:

Not specified

Medical Surveillance:

Yes

Significant Work Activities:

Not Applicable