Regulatory Specialist Ii

hace 2 semanas

Desde casa, México IQVIA A tiempo completo

Job Overview

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
- Bachelor's Degree Degree in Lifescience or related discipline Req Or
- Master's 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;
- 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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