IQVIA BSc Regulatory Affairs Officer Job! Apply Now!

IQVIA BSc Regulatory Affairs Officer Job! Apply Now!

Reg Affairs Officer 2

Bengaluru, India

Full time

R1451333

Job Description

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.
• Ensures 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, including:
  • 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 and 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.
• Provides 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:
  • Preparation and review of FDA deficiency letters and other FDA responses.
  • Supporting the Annual Report Coordinator on the FDA Annual Report by preparing and reviewing sections, reviewing the document plan, and the report content before submission to FDA.

Qualifications

• Bachelor’s Degree in Life Sciences or a related discipline, or a Master’s Degree in Life Sciences or a related discipline (required).
• At least 3-4 years of relevant experience.
• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws, and related guidelines, as appropriate.
• Possesses specific regulatory or technical expertise.
• Strong interpersonal communication (oral and written) and organizational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Proficiency in 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 procedures consistently and provide independent thought to assist in process improvements.
• Ability to make decisions on discrete tasks under senior supervision.
• Advanced knowledge within a specific discipline, typically gained through extensive work experience and/or education.
• Ability to make adjustments or recommend enhancements in systems and processes to solve problems or improve effectiveness of job area.
• 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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