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.

• May be involved in a Regulatory and/or IQVIA Initiative;

• Performs other tasks or assignments, as delegated by Regulatory management;

• May manage meetings with Regulatory Agencies;

• May be assigned as Reviewer and/or Approver for Regulatory standard operating porcedures or cross-functional standard operating porcedures owned by other operations;

• May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative;

• Performs other duties, as business needs require;

Qualifications

• Bachelor's Degree Degree in Lifescience or related discipline Req Or

• Master's Degree Degree in Lifescience or related discipline

• At least 8 years relevant experience

• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;

• Possesses a specific regulatory or technical expertise. Sufficient knowledge of managing regulatory projects, project deliverables on a time bound manner;

• Expert in planning and delivering work on time keeping quality parameter in mind;

• Knowledge of regulatory procedures in appropriate region – particularly marketing authorization transfers and relevant cross-functional dependencies;