Regulatory Affairs Manager

Job Overview

Individual contributor with advanced knowledge acquired from several years of experience in the professional discipline. Works independently under limited supervision.

Essential Functions

• Acts as a Regulatory Team Leader on complex projects which may include technical writing and / or may act as a Project Manager for a stand-alone project with guidance from senior staff as appropriate;
• Competently writes regulatory and / or technical documents with minimal review by senior staff;
• Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues;
• Undertakes detailed review and management of budgets related to projects including out of scope activities. Ensures revenue is recognised and challenges when appropriate may seek guidance from senior staff as appropriate;
• May give guidance to junior colleagues including feedback on the quality of technical documents and may assist in their training and development;
• May present to clients at bid defense meetings by phone or in person for a range of regulatory deliverables at discretion of senior staff;

May write new regulatory standard operating procedures and / or propose revisions and / or act as reviewer for regulatory standard operating procedures as assigned and appropriate.

Performs other duties as business needs require;

Qualifications

Bachelors Degree Degree in Lifescience or related discipline Req Or

Masters Degree Degree in Lifescience or related discipline

At least 8 years relevant experience

Applicable certifications and licenses as required by country state and / or other regulatory bodies

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at

Required Experience :

Manager

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1