FDA Regulatory Affairs Manager Job Description
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 involves 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 customer complaints and queries on FDA-related issues.
FDA Regulatory Affairs Manager Skills and Specifications
- Must have through understanding of FDA regulation and pertinent state and federal laws governing pharmaceutical products manufacturing and marketing.
- Must have a good foundation in laboratory testing methodologies
- Must be willing to work long hours even under extreme work pressures
- Must have excellent verbal and written communication skills
- Must have excellent organizational and managerial skills
- Must 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 basic.
- A master’s degree in management or business administration or equivalent in years of experience in a management position is preferred
FDA Regulatory Affairs Manager Salary
The median salary for Regulatory Managers in 2009 was $44.52 hourly or $92,600 annually. Salaries vary depending on company size and location.