About Abbott

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.

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.
• We offer flexible work policies that allow a healthy balance between personal and professional life
• We invest in the development of our employees through training and growth opportunities
• We foster an environment where every voice is heard and valued

The Opportunity

This position works out of our Mississauga location in the Nutrition division. 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

As an individual contributor, the function of a Regulatory Affairs Senior Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may 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

Provide regulatory input to product lifecycle planning

• Assist in the development of regulatory strategy and update strategy based upon regulatory changes
• Understand, investigate and evaluate regulatory history/background in order to assess regulatory implications
• Understand the business environment and the regulatory environment in formulating strategy
• Participate as a team member – actively contribute to the team process, commits to team goals, expresses opinion and expertise and shares ideas freely
• Communicates project status, regulatory requirements, regulatory timelines, and other pertinent information to the RA teams, core functional teams, and other cross-functional colleagues.
• Review of technical documentation for regulatory compliance; evaluation of product and manufacturing development and subsequent changes for regulatory compliance
• Assist with review and approval of labels and subsequent label changes for compliance.
• Support development and execution of regulatory assessments to ensure compliance and successful marketing of nutritional and Natural Health products in Canada
• Provide support to product claim assessments.
• Review and approve advertising and promotional items to ensure regulatory compliance
• Maintain data in electronic systems.

Support product submission process

• Where applicable, determine and communicate submission requirements

• Where applicable, assist in identifying data needed and ensuring they are effectively presented for the registration of nutritional and Natural Health products in Canada

• Where applicable, compile, prepare, review, submit, and monitor regulatory submissions and monitor impact of changing regulations on submission strategies

• Where applicable, interact with regulatory authorities during the development and review process when applicable to ensure submission success.

Contribute to the regulatory knowledge of the Regulatory Affairs team

• Interpret and share regulatory requirements for the Canada business

• Assist in monitoring the regulatory environment, assessing impact of pending regulatory changes and developing strategy and implementation plans for the organization

• Assist in SOP development and review

Required Qualifications

• Undergraduate University studies in Sciences, Dietetic/Food Science preferred
• 3 to 5 years of related experience in regulatory affairs in a regulated industry or experience working in Scientific/Medical Affairs in a regulated industry
• Communicate effectively verbally and in writing, with diverse audiences and personnel
• Work with people from various disciplines and cultures
• Communicate internally and externally with regulatory trade associations
• Write and edit technical documents
• Pay strong attention to detail
• Think analytically
• Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
• Exercise good and ethical judgment within policy and regulations
• Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues
• Define regulatory strategy with supervision
• Manage regulatory deliverables of projects, defining requirements and timelines.
• Organize and track complex information
• Canada Regulations, policies and guidance documents related to foods, specialized nutritional products, Natural Health Products and packaging.
• Understanding of regulatory processes and submission requirements
• Principles and requirements of promotion, advertising and labeling.
• Evidence based knowledge of nutrition across lifecycle and disease states
• Individuals execute and manage technical and scientific regulatory activities. Must function with limited supervision as a decision-maker on regulatory issues and must assure that deadlines are met.
• Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements. Work is reviewed upon completion to ensure that objectives have been met. Individual is recognized as a trusted partner in work group.
• Understands business environment and relates extensive knowledge of internal and external activities to trends.
• Provides technical leadership to cross-functional teams.
• Participates in the development of others by facilitating training and providing feedback and guidance.
• May lead a cross-functional project team.
• Exercises judgment with limited supervision.
• Advanced oral and written proficiency in English
• Advanced knowledge of of basic computer software like MS Office (Word, Excel and PowerPoint), Internet and specialized softwares/platforms.
• Intermediate knowledge of specific databases
• Ability to travel within Canada 5-10% of the time
• Possess a valid passport for international travel (5-10%) of the time

Preferred Qualifications

• Graduate Studies preferred
• Beginner oral and written proficiency in French

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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