FDA Regulatory Affairs Manager Job Description

May 25, 20120 Comments

Pharmaceutical FDA Regulatory Affairs Manager Job Profile and Description

Pharmaceutical companies employ Regulatory Affairs Managers in charge of submitting their products for FDA approvals for marketing new drug formulation, certification for prescriptive medication and compliance with FDA recommended good housekeeping and manufacturing standards. The responsibility entails overseeing the pertinent medical tests in a laboratory environment for purposes of FDA certification.

FDA Regulatory Affairs Manager Duties and Responsibilities

  • Direct the preparation, documentation and submission of FDA applications.
  • Review all regulatory agency compliance materials to guarantee accuracy, timeliness, comprehensiveness, and obedience with regulatory standards.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • Create or implement regulatory affairs rules and procedures to make sure that regulatory compliance is sustained or enhanced.
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • Provide responses to regulatory agencies regarding product information or issues.
  • Maintain current knowledge of relevant regulations including proposed and final rules.
  • Maintain database of FDA-approved and marketing approved drugs.
  • Respond to client complaints and queries on FDA-related issues.

FDA Regulatory Affairs Manager Skills and Specifications

  • Should have through understanding of FDA regulation and pertinent state and federal laws governing pharmaceutical products manufacturing and marketing.
  • Should have a good foundation in laboratory testing methodologies
  • Should be willing to work long hours even under extreme work pressures
  • Should have excellent verbal and written communication skills
  • Should have excellent organizational and managerial skills
  • Should have computer literacy to operate standard word processing, spreadsheets, presentation and internet application.

FDA Regulatory Affairs Manager Education and Qualifications

  • A 4-year college degree in the sciences is a basic requirement.
  • A master’s degree in management or business administration or equivalent in years of experience in a management position is ideal

FDA Regulatory Affairs Manager Salary

The average salary for Regulatory Managers is $45 per hour or $95,000 per annum. Salaries vary depending on organization size and location.

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