Job Overview
• Plans and coordinates activities to ensure regulatory lifecycle management activities and approvals are achieved by the Local Operating Company (LOC) in a timely manner for all globally approved products.
• Acts as the point of contact for LOCs and other stakeholders for assessing proposed changes including CMC and Labelling related changes.
• Works closely with LOCs and other stakeholders, as appropriate, to gain familiarity and clarify regulatory requirements to support preparation of submission packages including responses.
• Ensure applicable SLAs (Service Level Agreements) and KPIs (Key Performance Indicators) for their work are met, including follow up with GLL (Global Labelling Lead) and CMC Leads on deliverables to meet deadlines for Health Authority queries.
• Prepares deliverables (Variations, Supplements, Renewals, Referrals, New Marketing Authorisations including Line Extensions (also in Emerging Markets), MAH transfers including repatriation, Health Authority and LOC queries, Dossier due diligence, Core submission (document plan and supporting documents) for renewals, national / MRP (Mutual Recognition Procedure) / DCP (Decentralised Procedure) Response documents for Referrals, Submission approvals, written advice to LOCs on submission queries, and post-submission support, Management of submission status with partner LOCs, GRL input into product quality reviews, GRL initiation of applicable non-CMC change requests in TrackWise as well as providing SME assessments in TrackWise, FDA Annual Report submission)
• Conducts QC review for deliverables prepared by GRL support and other GRLs
• Operates in line with client QMS procedures for the regulatory services provided
• Raises suspected quality events and process deviations with the RA Lead.
• Provide regulatory support for PSURs (Product Safety Update Reports) / PBRERs (Periodic Benefit Risk Evaluation Reports) PADER (Periodic Adverse Drug Experience Report - FDA) or RMPs (Risk Management Plans), as required
• As US Regulatory Lead is responsible for the preparation and review of FDA deficiency letters and other FDA responses.
• US Regulatory Lead is responsible for supporting the Annual Report Coordinator on the FDA Annual Report by preparing and reviewing sections, reviewing the doc plan and the report content before submission to FDA.
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
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