Job Description

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 107,000 colleagues serve people in more than 160 countries

JOB DESCRIPTION:

Senior Regulatory Affairs Specialist

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.

Nourish the world and your career as part of the Nutrition team at Abbott.

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.

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

The Senior Regulatory Affairs Specialist is responsible for compliance with applicable Corporate and Divisional Policies and procedures and Regulatory SOPs.

WHAT YOULL DO

* * Provide support for the regulatory department to ensure efficient and compliant business processes and environment.
* Execute regulatory tasks and play a consultative role by partnering across business functions.
* Assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products in LATAM (Latin America) region.
* Prepare and/or review documentation or oversee preparation of documentation needed for registration in LATAM region.
* Provide technical leadership to business units.
* Assist in Regulatory SOP development and review.
* 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 for LATAM region.
* Understand, investigate and evaluate regulatory history/background of nutritional products in order to assess regulatory implications for approval.
* Understand the business environment and relate extensive knowledge of internal and external activities to trends; determine 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.
* Review of technical documentation for regulatory submissions; evaluation of product and manufacturing changes for regulatory implications; review and approval of label changes, advertising and promotional items.
* Support development and execution of regulatory assessments to ensure compliance and successful registration/approval of nutritional products in LATAM.
* Provide regulatory and registration requirements to support product development.
* Determine and communicate submission and approval to the core functional product team.
* Provide support to product claim assessments.
* Provide RA feedback in project management meetings for LATAM projects.
* Support product deficiencies response.
* Communicate project status, regulatory timelines to the RA teams and core functional product team.
* Participates as a Team Member: Actively contributes to the team process, commits to team goals, expresses opinions and shares ideas freely.
* Contributes to the creation of the team's mission objectives and strategies, accepts team decisions and works toward their implementation

EDUCATION AND EXPERIENCE, YOULL BRING

Required

* Bachelor's degree (or equivalent) is required - preferred area of focus in science (nutrition, biology, chemistry, nutrition, dietetics, microbiology, immunology, medical technology, pharmacy, and pharmacology), math, engineering, or medical fields.

* M.S. in a technical area or M.B.A. is preferred.

* A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

Note: Higher education may compensate for years of experience or vice versa.

Preferred

* 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:
* International regulations relating to nutritional products eg: Codex standards, and/or LATAM regulations preferred.
* Principles and requirements of promotion, advertising and labeling.
* Communication skills and ability to:
* Communicate effectively verbally and in writing in Spanish and English.
* Communicate with diverse audiences and personnel.
* Work with and negotiate with people from various disciplines, organizations, and cultures.
* Follow scientific arguments, identify regulatory scientific data needs and, with supervision, solve regulatory issues and define regulatory strategy.
* Evaluate various technical alternatives.
* Other skills:
* Strong attention to detail.
* Create and manage project plans and timelines.
* Think analytically; organize and track complex information.
* Proficient computer skills.

Accountability/Scope:

* Execute and manage technical and scientific regulatory activities.
* Function independently as a decision-maker on regulatory issues and assure that deadlines are met.
* Effectively communicate, prepare, and negotiate internally and externally with various regulatory agencies.
* May lead a cross-functional project team

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

* 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.

JOB FAMILY:

Regulatory Operations

DIVISION:

AN Abbott Nutrition

LOCATION:

United States > Abbott Park : AP06C Floor-4

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf