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Special Regulatory Affairs – Nutrition – Abbott Park , IL or Ireland

Abbott Laboratories

This is a Contract position in Detroit, MI posted October 14, 2021.

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 109,000 colleagues serve people in more than 160 countries.

Regulatory Affairs Specialist Our nutrition business develops science-based nutritional 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 lives.

Our location in Abbott Park, IL or Ireland, currently has an opportunity for a Regulatory Affairs Specialist .

Primary Function/Primary Goals/Objectives : 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.

IN SPONSIBILITIES Major Responsibilities: Ensures timely approval of Nutritional products, functional foods & drugs for assigned region/countries.

Possess well developed skills in directing development of product registration dossiers, submission, progress reports, deficiencies, amendments, etc … Provide regulatory input to product lifecycle planning.

Assist in the development of regulatory 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.

Participate in risk-benefit analysis for regulatory compliance.

Plan and organize non-routine tasks with approval; initiate and/or maintain work schedule.

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 labeling, 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.

Supervisory/Management Responsibilities (Influence/Impact/Leadership): 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.

Education: 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.) Skills/Experience Requirements: 2-3 plus years of experience in regulatory preferred, but may consider quality assurance, research and development, scientific affairs, operations, or related area.

Regulatory knowledge of (as applicable
– note: This knowledge may be developed through tenure in this position.): a.

Regulatory requirements, registration submissions, guidelines, policies, standards, practices, history, ethics, agency structure and processes, etc.

b.

GxPs (GMPs, GLPs, GCPs).

c.

Principles and requirements of promotion, advertising, and labeling.

Communication skills and ability to: a.

Communicate effectively verbally and in writing.

b.

Communicate with diverse audiences and personnel.

c.

Work with and negotiate with people from various disciplines, organizations, and cultures.

d.

Evaluate various technical alternatives.

Other skills: a.

Strong attention to detail.

b.

Create and manage project plans and timelines.

c.

Think analytically; organize and track complex information.

d.

Proficient computer skills.

Accountability/Scope: Execute and manage technical and scientific regulatory activities.

Participates in conflict resolution at the team level.

May lead a departmental project team.

WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career.

We offer: A fast-paced work environment where your safety is our priority Production areas that are clean, well-lit and temperature-controlled Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter AbbottNews and AbbottGlobal.