Executive Regulatory Affairs Labelling

Job Description

* Position Name: Regulatory Affairs Labeling ExecutiveLocationKurlaBand/Grade:1A/BDepartmentRegulatory AffairsFLSAExemptSub FunctionLabelingLast updatedOctober 14, 2020SummaryResponsible 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.ManagerChief Labeling Manager, Regulatory Affairs Key StakeholdersExternalInternalCountry Distributors, Health Authority (HA), CMOs and external partnersCross-Functional: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Project Management, Senior ManagementEssential Duties and Responsibilities

• Ensures all artworks and labeling (labels, cartons, package inserts, patient package inserts) required are accurate and compliant by managing evaluations, maintenance, reviews and approvals with cross-functional teams for regulatory submissions.
• Understands and applies Canadian and US requirements for Text of Artwork, Packaging Insert and Medication guide preparation and review
• Reviews ANDA s, amendments, supplements and annual reports to FDA
• Manages required labeling updates, proofreading, and version control
• Maintains country/regional labelling in compliance with Piramal Labelling processes and external requirements such as management of the International PI document, US PI and EU PI (for Centralized, Mutual Recognition and Decentralized procedure submissions)
• Coordinates Content of US Labeling/Drug Listing SPL generation and review for assigned products.
• Acts as subject matter expert in Piramal Global Labelling process for US/EU product information requirements.
• Authors documentation to support the Global Labelling Committee, as required
• Effective planning, prioritization, communication and delivery of quality labelling documents according to company timelines and submission requirements.
• Maintains knowledge of, and familiarity with FDA/EMA/key international market regulations and ICH labeling guidelines.
• Creates and update artwork files in line with HA requirements, distributors and business partner requests.
• Proofreads all types of label copy/annotation/etc. at all development stages as well as final label copy to ensure accuracy of labeling.
• Creates SPL for US Human and Vet product submissions, drug listing, annual establishment registration and annual self-identification for GDUFA.
• Monitors and processes innovator-labeling updates for existing generic products and ensure compliance with innovator updates, including side-by-side comparison with RLDs.
• Contributes to the development and/or review of all labeling aspects included in Promotional Material.
• Maintains all RA tracking tools, databases, and central repositories for labeling components.

Key Competencies (knowledge, skills and abilities every person must possess to be successful)

• Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers
• Excellent verbal and written communication skills
• Quality review for standard operating procedures
• Knowledge of global regulatory filings preferred
• Medical device experience a plus
• Intermediate skills in Microsoft Office, particularly Excel and Word

Reporting to this position: N/AGeneral Oversight and Direction:Receives moderate to limited supervision working from objectives set by Manager. Employee organizes and carries out most assignments in accordance with standard practices, instructions or previous training. Employee handles some situations independently., *Education/Experience

• BS/MS Degree in a science/Pharma or related field
• Minimum of 2-5 years experience in a regulated industry; Global experience including US, EU and major Rest of World markets preferred

Keyskills :
quality assurancepackage insertssupply chainquality controlmarketingmicrosoft officemedical affairschange requestsannual reportscustomer servicecritical care