Senior Regulatory Affairs Specialist

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

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® and Glucerna®, to help get the nutrients they need to live their healthiest life.

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 will have access to:

Career development with an international company where you can grow the career you dream of.

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 Opportunity

As the Senior Regulatory Affairs Specialist, 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 and/or conducting regulatory assessments using worldwide data. Prepare and submit documentation or oversee preparation of documentation needed for registration worldwide. Provide technical leadership to business units.

What You’ll Do

Responsible for compliance with applicable Corporate and Divisional Policies and procedures and Regulatory SOPs.

Work with markets and relevant SMEs to track emerging legislative changes and industry trends to support impact assessments and appropriate handover processes to cross functional teams.

Support and/or lead development of regulatory strategies for new product innovations, line extensions and market entry.

Partner with R&D, commercial, quality assurance, supply chain teams to address technical and regulatory hurdles.

Execute regulatory tasks and manage key projects critical to support AN strategy to futureproof business needs and changes.

Assist in Regulatory SOP development and/or review; identify areas for improvement and optimization in regulatory quality systems and processes.

Depending on specific role, may be involved in various regulatory activities including review of scientific documentation, regulatory submissions and follow-up, evaluation of product and manufacturing changes for regulatory implications, support compliance audits,

Maintaining annual licenses, registrations, listings and patent information, review and approval of label changes, advertising and promotional content, and providing regulatory input to product safety issues and product recalls.

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 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).

6-7 years of experience in regulatory preferred, but may consider quality assurance, research and development, scientific affairs, operations, or related area.

4-5 years of experience in a regulated industry (e.g., infant and adult specialized nutritionals, medical/pharmaceutical products).

Regulatory knowledge of regulatory requirements, guidelines, policies, standards, practices, history, ethics, agency structure and processes.

Knowledge of GxPs (GMPs, GLPs, GCPs).

Knowledge of principles and requirements of promotion, advertising and labeling.

Specialized nutrition, food and pharmaceutical regulations, especially in Asia is an added advantage.

Strong communication skills with the ability to communicate effectively verbally and in writing, communicate with diverse audiences and personnel, and work with and negotiate with people from various disciplines, organizations, and cultures.

Ability to follow scientific arguments, identify regulatory scientific data needs and, with supervision, solve regulatory issues and define regulatory strategy.

Ability to evaluate various technical alternatives.

Strong attention to detail.

Ability to create and manage multiple project plans and timelines.

Ability to think analytically; organize and track complex information.

Proficient computer skills.

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.

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