Regulatory Affairs Officer Job Description

Regulatory Affairs Officer Duties and Responsibilities

Regulatory Affairs Officer job description should contain a variety of functions and roles including:

• Preparing submissions of licence variations and renewals to strict deadlines;
• Ensuring that a company’s products comply with regulations;
• Keeping abreast of international legislation, guidelines and customer practices in all countries that the company is exporting to;
• Negotiating with regulatory authorities for marketing authorisation;
• Specifying storage, labelling and packaging requirements.
• Collecting, collating and evaluating scientific data that has been researched by colleagues;
• Developing and writing clear arguments and explanations for new product licences and licence renewals;
• Planning and developing product trials and interpreting trial data;
• Advising scientists and manufacturers on regulatory requirements;
• Reviewing company practices and providing advice on changes to systems;
• Liaising with, and making presentations to, regulatory authorities;
• Monitoring and setting timelines for licence variations and renewal approvals;
• Working with specialist computer software and resources;
• Writing clear, accessible product labels and patient information leaflets;
• Providing strategic advice to senior management throughout the development of a new product;
• Project managing teams of colleagues involved with the development of new products;
• Undertaking and managing regulatory inspections;

Regulatory Affairs Officer Requirements / Skills / Qualifications

Regulatory Affairs Officer job description should include these common skills and qualifications:

• Bachelor's degree in any of the sciences.
• Understanding of both legal and scientific matters
• Ability to grasp new concepts quickly and to assimilate and evaluate scientific data
• Analytical and problem-solving skills
• Confidence to report to management
• Team-working skills and the ability to lead and motivate others
• Project-management skills
• Integrity and a professional approach to work
• Tact and diplomacy
• Written and oral communication skills
• Attention to detail
• Strong negotiation skills
• IT skills, particularly in relation to using databases and familiarity with commercial software
• Ability to work under pressure and to strict deadlines
• Awareness of the legislation governing the approval of products.

As a hiring manager, recruiting an ideal Regulatory Affairs Officer starts with crafting a good job description. Use this Regulatory Affairs Officer job description template to save yourself time and help you attract the most qualified candidates. Feel free to revise it to meet your specific needs.

Job seekers interviewing for the role of a Regulatory Affairs Officer may also reference it in preparation for the interview.