1+ months
2018-03-152018-07-20

Senior Regulatory Affairs Specialist

Abbott
United States

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

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

  • Assist in SOP development and review  Provide regulatory input to product life cycle planning.
  • Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
  • Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
  • Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.
  • Determine trade issues to anticipate regulatory obstacles.
  • Determine and communicate submission and approval requirements.
  • Participate in risk benefit analysis for regulatory compliance.
  • Assess the acceptability of quality, pre-clinical and clinical documentation for submission filing.
  • Compile, prepare, review and submit regulatory submission to authorities.
  • Monitor impact of changing regulations on submission strategies.
  • Monitor applications under regulatory review.
  • Monitor and submit applicable reports to regulatory authorities.
  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
  • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
  • Maintain annual licenses, registrations, listings and patent information.
  • Assist compliance with product postmarketing approval requirements.
  • Review and approve advertising and promotional items to ensure regulatory compliance.
  • Assess external communications relative to regulations.
  • Review regulatory aspects of contracts.
  • Assist with label development and review for compliance before release.
  • Submit and review change controls to determine the 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/ issue management program.
  • Ensure product safety issues and productassociated events are reported to regulatory agencies.
  • Provide regulatory input for product recalls and recall communications.

    Minimum Education & Experience

    • 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 (e.g., medical products, nutritional). 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


      Job Family: Regulatory Operations
      Division: ASJM Abbott St. Jude Medical
      Additional Location: United States - South Carolina - Liberty
      Travel: Yes, 15 % of the Time
      Medical Surveillance: No
      Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Senior Regulatory Affairs Specialist

Abbott
United States

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Abbott

US

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