Sr. Specialist Regulatory Affairs – Nutrition

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 115,000 colleagues serve people in more than 160 countries.

WORKING AT ABBOTT

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self, and live a full life. You’ll also have access to:

• 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, Medical Benefits start day 1
• Vacation – 3 weeks accrued vacation (1st yr. is prorated) + vacation buy program + 3 personal days + 10 paid holidays
• Company Paid Pension Plan
• 401(k) retirement savings with a generous company match of 5%
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit – an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

POSITION SUMMARY

As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual will execute tasks and play a consultative role by partnering with cross-business functions. The individual is responsible for compliance with applicable Corporate and Divisional Policies and procedures and Regulatory SOPs.

WHAT YOU’LL DO

PRIMARY FUNCTION/PRIMARY GOALS/OBJECTIVES:

• 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 worldwide.
• Prepare and submit documentation or oversee preparation of documentation needed for registration worldwide.
• Provide technical leadership to business units.

MAJOR RESPONSIBILITIES:

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures and Regulatory SOPs.
• 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.
• 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 Sr Regulatory Affairs Specialist may be involved in various regulatory activities (review of documentation; regulatory submissions and follow-up; evaluation of product and manufacturing changes for regulatory implications; maintaining annual licenses, registrations, listings with regulatory IT systems management and data analytics).

INFLUENCE/IMPACT/LEADERSHIP:

• May provide direction and guidance to exempt and/or skilled non-exempt levels of employees; act as a mentor to less-experienced staff.
• Participate in the development of others by facilitating training and providing feedback and guidance. Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.
• Perform work without appreciable direction.

EDUCATION AND EXPERIENCE, YOU’LL BRING

REQUIRED

• Bachelor’s degree is required – preferred area of focus in science (biology, chemistry, nutrition, dietetics, microbiology, immunology, medical technology, pharmacy, and pharmacology), math, engineering, or medical fields.
• 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). Note: Higher education may compensate for years of experience or vice versa.

PREFERRED

• 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.
• Regulatory knowledge of (as applicable): 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 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. solve regulatory issues and define regulatory strategy. e. 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:

1. Execute and manage technical and strategic regulatory activities.
2. Function independently as a decision-maker on regulatory issues and assure that deadlines are met.
3. Effectively communicate, prepare, and negotiate internally and externally with various regulatory agencies.
4. Ability to lead a cross-functional project team.

APPLY NOW

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

LEARN MORE ABOUT OUR HEALTH AND WELLNESS BENEFITS, WHICH PROVIDE THE SECURITY TO HELP YOU AND YOUR FAMILY LIVE FULL LIVES: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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.

The base pay for this position is $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted.