Mar 07, 2019

REGULATORY AFFAIRS SPECIALIST I

  • Abbott
  • Pleasanton, CA, USA
Full time Pharmaceutical

Job Description

RESPONSIBILITIES

  • Maintains current registrations by preparing documentation required and submitting documentation on or in advance of schedule to achieve and or exceed departmental and organizational objectives. Maintain and enter regulatory submission data into database and file systems.
  • Review protocols and reports to support regulatory file
  • Completes daily work to meet established schedule with guidance from supervisor on prioritization of tasks.
  • May exercise authority within pre-established limits and approval. 
  • Understanding and knowledge of Medical and regulatory terminology
  • Knowledge of regulatory history, guidelines, policies, standards, practices, requirements and precedents
  • Familiarity of regulatory agency structure (ex. FDA), processes and key personnel
  • Principles and requirements of applicable product laws; Submission/registration types and requirements (either FDA or international regulatory agencies)
  • Principles and requirements of promotion, advertising and labeling
  • Provides support for review and update of regulatory processes and procedures.
  • Conducts reviews of product and manufacturing changes for compliance with applicable regulations
  • Partner with cross-functional team to support product release process
  • Support all company initiatives as identified by management in support of Quality Management System (QMS) and other regulatory requirements
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors and vendors.
  • Complies with US FDA and international regulations and regulatory requirements, company policy and operating procedures.

QUALIFICATIONS

  • BA or BSc degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, psychology), math, engineering, or medical fields is preferred.
  • 2+ years experience in a regulated industry (e.g., medical products, pharmaceuticals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, clinical affairs, operations, or related area.
  • Strong organizational and follow-up skills as well as attention to detail
  • Multitasks, prioritizes and meets deadlines in timely manner
  • Demonstrated ability to think analytically, strategically and critically
  • Review, analyze documentation and work on projects/problems of limited scope
  • Research and locate information on regulatory requirements and similar products
  • Exercises judgment within defined procedures and practices to determine appropriate action
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Ability to leverage and/or engage others to accomplish projects
  • Strong verbal and written communications
  • Apply business ethical standards
  • Ability to travel approximately 5%, including internationally
  • Job Breakdown

    Job Breakdown

  • 30909608

  • Regulatory Operations

  • CAHF Cardiac Arrhythmias & Heart Failure

  • Pleasanton, California, United States of America

  • Yes, 5 % of the Time

  • Not Applicable

  • Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

    Keyboard use (greater or equal to 50% of the workday)


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