Executive Regulatory Affairs Labelling Job in Piramal Enterprises Ltd.

Position Name: Regulatory Affairs Labeling Executive

Regulatory Affairs

Last updated

Summary

Responsible for all artworks and labeling components of Piramal Critical Care Products Worldwide with adherence to the labeling processes to ensure compliance with innovator labeling, internal company, external partners and GMP standards and specifications. Will participate in a cross-functional team environment as necessary to ensure labeling documents and associated change requests are medically and scientifically accurate and that they comply with regulatory standards, meet company needs and accurately assess current strategy and global regulations.

Chief Labeling Manager, Regulatory Affairs

Country Distributors, Health Authority (HA), CMOs and external partners

Cross-Functional: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Project Management, Senior Management

EssentialDuties and Responsibilities

• Ensures allartworks and labeling (labels, cartons, package inserts, patient packageinserts) required are accurate and compliant by managing evaluations,maintenance, reviews and approvals with cross-functional teams for regulatorysubmissions.
• Understandsand applies Canadian and US requirements for Text of Artwork, Packaging Insert andMedication guide preparation and review
• ReviewsANDAs, amendments, supplements and annual reports to FDA
• Managesrequired labeling updates, proofreading, and version control
• Maintainscountry/regional labelling in compliance with Piramal Labelling processes andexternal requirements such as management of the International PI document, USPI and EU PI (for Centralized, Mutual Recognition and Decentralized proceduresubmissions)
• CoordinatesContent of US Labeling/Drug Listing SPL generation and review for assignedproducts.
• Acts assubject matter expert in Piramal Global Labelling process for US/EU productinformation requirements.
• Authors documentationto support the Global Labelling Committee, as required
• Effectiveplanning, prioritization, communication and delivery of quality labellingdocuments according to company timelines and submission requirements.
• Maintainsknowledge of, and familiarity with FDA/EMA/key international market regulationsand ICH labeling guidelines.
• Creates andupdate artwork files in line with HA requirements, distributors and businesspartner requests.
• Proofreadsall types of label copy/annotation/etc. at all development stages as well asfinal label copy to ensure accuracy of labeling.
• Creates SPLfor US Human and Vet product submissions, drug listing, annual establishmentregistration and annual self-identification for GDUFA.
• Monitorsand processes innovator labeling updates for existing generic products andensure compliance with innovator updates, including side by side comparisonwith RLDs.
• Contributesto the development and/or review of all labeling aspects included inPromotional Material.
• Maintainsall RA tracking tools, databases, and central repositories for labelingcomponents.

KeyCompetencies (knowledge, skills and abilities every person must possess to besuccessful)

• Excellent customer service skills andprofessional demeanor at all times to interface effectively with all internaland external customers
• Excellent verbal and written communicationskills
• Quality review forstandard operating procedures
• Knowledge of globalregulatory filings preferred
• Medical deviceexperience a plus
• Intermediate skills inMicrosoft Office, particularly Excel and Word

• BS/MS Degree in a science/Pharma or relatedfield
• Minimum of 2-5 years experience in aregulated industry; Global experience including US, EU and major Rest of Worldmarkets preferred

Receives moderateto limited supervision working from objectives set by Manager. Employeeorganizes and carries out most assignments in accordance with standardpractices, instructions or previous training. Employee handles some situationsindependently.

You are expectedto follow all policies, procedures and guidelines, conducting yourself in waysthat protect the interests and safety of all employees and the company.

The abovestatements reflect the general duties and responsibilities considered necessaryto perform the essential functions of the job.This document should not be considered a fully detailed description ofall the work requirements of the position. Piramal Critical Care may change thespecific job duties with or without prior notice based on the needs of the organization.

Qualifications