• Senior Regulatory Affairs Specialist Jobs in United States Of America - 23296293

  • Abbott India Ltd
  • United States Of America, Usa
  • Save Job
  • 3 - 4 Years
  • Posted : above 1 month

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 103,000 colleagues serve people in more than 160 countries

JOB DESCRIPTION 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 may execute tasks and play a consultative role by partnering across business functions The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation

Main Responsibilities

Work with project team to develop key deliverables that need to be tracked and managed Manage detailed plans and anticipate possible road blocks to meeting plan
Take ownership of the project and develop effective working relationships and communication with team members and business partners to develop plans to meet the timelines, then follow up on those deliverables to hold self and others accountable for commitments
Leverage MS Excel and MS Access database to track and provide team updates on progress against project deliverables Facilitate negotiations to what is aggressively achievable to exceed EPD timeline expectations
Work independently and with team members to identify and then mitigate risks/issues
Understand limitations of business partners capabilities and processes, then work collaboratively to create efficiencies or escalate challenges to efficiencies to eliminate things that slow down the process
Update Regulatory Intelligence System as information is acquired to support future submissions
Work with project team to develop key deliverables that need to be tracked and managed Manage detailed plans and anticipate possible road blocks to meeting plan
Take ownership of the project and develop effective working relationships and communication with team members and business partners to develop plans to meet the timelines, then follow up on those deliverables to hold self and others accountable for commitments
Leverage MS Excel and MS Access database to track and provide team updates on progress against project deliverables Facilitate negotiations to what is aggressively achievable to exceed EPD timeline expectations
Work independently and with team members to identify and then mitigate risks/issues
Understand limitations of business partners capabilities and processes, then work collaboratively to create efficiencies or escalate challenges to efficiencies to eliminate things that slow down the process

Qualifications

Bachelors degree (or equivalent); Bachelors degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society) 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area 3-4 years experience in a regulated industry (eg, medical products, nutritionals) Note Higher education may compensate for years of experience Regulatory history, guidelines, policies, standards, practices, requirements and precedents Regulatory agency structure, processes and key personnel Principles and requirements of applicable product laws Submission/registration types and requirements GxPs (GCPs, GLPs, GMPs) Principles and requirements of promotion, advertising and labeling International treaties and regional, national, local and territorial trade requirements, agreements and considerations Domestic and international regulatory guidelines, policies and regulations Ethical guidelines of the regulatory profession, clinical research and regulatory process Regulatory history, guidelines, policies, standards, practices, requirements and precedents Regulatory agency structure, processes and key personnel Principles and requirements of applicable product laws Submission/registration types and requirements GxPs (GCPs, GLPs, GMPs) Principles and requirements of promotion, advertising and labeling International treaties and regional, national, local and territorial trade requirements, agreements and considerations Domestic and international regulatory guidelines, policies and regulations Ethical guidelines of the regulatory profession, clinical research and regulatory process Pay strong attention to detail Manage projects Create project plans and timelines Think analytically Organize and track complex information Exercise judgment within broadly defined practices and policies in selecting methods, techniques and 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 and cross group dependencies/ relationships Define regulatory strategy with supervision Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare, Manufacturing/Industrial
Functional Area : IT Software : Software Products & Services
Role : Software Engineer
Salary : As per Industry Standards
Deadline : 01st Feb 2020

Key Skills:

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