Reg Affairs Sr Specialist

Job Overview

Individual contributor with advanced knowledge acquired from several years of experience in the professional discipline. Works independently under very limited or no 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 recognized 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 procedures or cross-functional standard operating procedures 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 in Lifescience or related discipline.

• Master's Degree in Lifescience or related is a plus.

• At least 6+ years relevant experience: Knowledge of regulatory procedures in Brazil, particularly in registration and variations of synthetic and biological drug products as well as relevant cross-functional dependencies, planning and delivering work on time keeping high quality parameter in mind.

• Great working knowledge of Brazilian regulatory intelligence.

• Ability to work closely with client regional heads to determine submission strategy.

• Good understanding of CMC activities relevant to marketing authorization application and post approval submissions.

• Great working knowledge of Brazilian regulatory intelligence.

• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

• Strong software and computer skills, including Microsoft Office, and regulatory tools, as applicable.

• Ability to work on several projects, with direction from senior staff as appropriate.

• Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements.

• Ability to make decisions on discrete tasks under senior supervision;

• Experience of involvement in regulatory strategy and determination of documentation requirements, timelines, budgets for registration and variations of synthetic and biological drug products projects.

• Project leadership experience.

• Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area.

Required Experience

• Extensive experience in regulatory lifecycle management, including registration, post-approval variations, renewals, and other lifecycle activities for synthetic and biological drug products in Brazil.
• Strong experience in the assessment, preparation, review, submission, and management of post-registration applications and annual reports, ensuring compliance with applicable Brazilian regulatory requirements.
• Demonstrated experience in the management and oversight of regulatory submissions involving local legal documentation, Health Authority requirements, and GMP certification in Brazil, including documentation for CVS, VISA, COVISA, and ANVISA, as applicable.
• Solid experience with regulatory information management systems and regulatory impact assessments related to change controls, including evaluation of product, manufacturing, quality, and labeling changes.
• Demonstrated experience with CADIFA and associated lifecycle activities, including oversight and maintenance of regulatory documentation, product records, and lifecycle management data.
• Proven ability to independently manage multiple regulatory projects and complex activities, effectively prioritizing competing demands and delivering against challenging timelines.
• Experience in the assessment and interpretation of Brazilian regulatory legislation and requirements, providing strategic and high-impact regulatory guidance to cross-functional stakeholders.
• Experience representing Regulatory Affairs in cross-functional and external stakeholder meetings, including meetings conducted in English, providing project updates, discussing regulatory requirements, identifying risks, and driving resolution of regulatory matters.

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 https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.