Senior Regulatory Affairs Specialist

JOB DESCRIPTION:

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:

• Career development with an international company where you can grow the career you dream of
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• 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

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whetherit’sglucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than500,000 peoplewith diabetes from routinefingersticks.

The Opportunity

As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for theregulatory department to ensure efficient and compliant business processes and environment.The individualmay execute tasks and play a consultative role by partnering across business functions. The individual mayassistinidentifyingdata needed, obtaining thesedataand ensuring that they are effectively presented for theregistrationof products worldwide. The individual may prepare andsubmitdocumentation needed for registrationworldwide or may oversee such preparation.

MAIN RESPONSIBILITIES

• Strategic Planning: Assist in SOP development and review. Provide regulatory input to product lifecycleplanning. Continue to revisit and compare regulatory outcomes withinitialproduct concepts to makerecommendations on future actions.Assistin the development of regional regulatory strategy and updatestrategy based upon regulatory changes.
• Understand,investigateand evaluate regulatory history/background of class, disease/ therapeutic/diagnosticcontextin order toassess regulatory implications for approval.Determinetrade issues toanticipateregulatoryobstacles.Determineand communicate submission and approval requirements. Participate in risk-benefitanalysisfor regulatory compliance.
• Premarket: Assess the acceptability of quality,preclinicaland clinical documentation for submission filing.Compile, prepare,reviewandsubmitregulatorysubmissionto authorities.
• Monitorimpact of changing regulations on submission strategies. Monitor applications under regulatory review.Monitor and submit applicable reports to regulatory authorities.Evaluate proposed preclinical,clinicaland manufacturing changes for regulatory filing strategies.Negotiate and interact with regulatory authorities duringthedevelopment and review process to ensure submission approvalis important.
• Post market:Maintainannual licenses, registrations,listingsand patent information.Assistcompliance withproductpost marketing approval requirements.
• Review and approve advertising and promotional items to ensure regulatory compliance. Assess external communicationsrelativeto regulations. Review of regulatory aspects of contracts.Assistwith label development and review for compliance before release.
• Submitand review change controls todeterminethe level of change and consequent submission requirements. Analyze the input of cumulative product changes to current product submissions.
• Contribute to the development and functioning of the crisis/ issuemanagement program. Ensure product safety issues and product-associated events are reported to regulatory agencies. Provide regulatory input for product recalls and recall communicationsJobspecific responsibilities may include (choose applicable areas and expand asappropriate). Manage and oversee the preparation of high-quality global filings for sustaining changes and new product registration. Managerestofworld(all geographies outside the US and EU) submissions.
• Serveas a regulatory team member on product development and sustaining teams, providing clear, concise regulatory strategy to ensure applicable global requirements are met for product development and quality system products. •AssistcompanySME’sto interpret existing or new regulatory requirements for company products and procedures, labeling, marketing projects,testingand record keeping.May anticipate and advise on future regulatory trends and direction and recommend preemptive approaches for company regulatory.•Proactively track global regulatory requirement changes and work withGlobalStrategic Intelligence (GSI) team todisseminatethe information to all team members.

REQUIRED QUALIFICATIONS

• BachelorsDegree (± 16 years) Related field OR an equivalent combination of education and work experience
• MastersDegree (± 18 years) In Regulatory Affairs preferred and may be used in lieu of direct regulatory experience.
• Minimum 3years3-4years experiencein a regulated industry (e.g., medical products, nutritionals). 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or relatedarea.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• Knowledge of: Regulatory history, guidelines, policies, standards, practices,requirementsand precedents. Regulatory agency structure and processes. Principles and requirementsofapplicable regulations and agency guidance. Submission/registrationtypes and requirements.GxPs(GCPs, GLPs, GMPs). Principles and requirementsofpromotion,advertisingand labeling. Ethical guidelinesofthe regulatory profession. Communication Skills or Ability to: Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents. Work with cross-functional teams. Work with people from various disciplines and cultures. Negotiate internally and externally with regulatory agencies. Cognitive Skills or Ability to: Pay strong attention to detail. Manage projects. Create andmaintainproject plans and timelines. Think analytically. Organize and track complex information. Exercise judgment within broadly defined practices and policies in selecting methods,techniquesand evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business. Exercise good and ethical judgment within policy and regulations. Use in-depth knowledge of business functions andcross groupdependencies/ relationships. Define regulatory strategy with supervision. Follow scientific arguments, identify regulatory scientific data needs and with supervisionsolveregulatory issues.