Senior Regulatory Specialist

Job Overview
Individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision.

Essential Functions
Acts as a Regulatory Team Leader on more complex projects which may include technical writing;
Prepares and/or reviews regulatory documentation in area of expertise as appropriate;
Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues present lessons learned and discuss customer comments;
Acts as an SME/ expert in Regulatory knowledge in Chemistry Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;
Understands the Scope of Work deliverables and management of budget for any given project and manages workload 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 on complex regulatory processes at large full service bid defense meetings by phone or in person;
May act as reviewer for regulatory standard operating procedures as assigned and appropriate;
May prepare and deliver regulatory training to IQVIA small groups or individuals;
Performs other tasks or assignments as delegated by Regulatory management;

Qualifications
Bachelors Degree Degree in Lifescience or related discipline Req Or
Masters Degree Degree in Lifescience or related discipline Req
At least 3-4 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;
Good solid interpersonal communication (oral and written) and organisation skills;
Ability to establish and maintain effective working relationships with coworkers managers and clients;
Strong software and computer skills including Microsoft Office publishing applications and tools as applicable;
Demonstrates self-motivation and enthusiasm;
Ability to work on several projects with direction from senior staff as appropriate;
Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements;
Ability to make decisions on discrete tasks under senior supervision;
Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;
Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
Problems faced are general and may require understanding of broader set of issues but typically are not complex;
Ability to adapt quickly to a rapidly changing environment;
Applicable certifications and licenses as required by country state and/or other regulatory bodies

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