IQVA Mumbai Hiring For Regulatory Affairs Specialist

Position: Regulatory Affairs Specialist - India

Location: Thane, Maharashtra

Job Responsibilities For IQVA Job

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;

Experience with clinical trial application in EU/US will be preferred.
• 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;

• 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

How To Apply For IQVA Job

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