Trainee Pharma Job Openings at Apotex – Apply Online Now
Trainee – Labelling, Regulatory Affairs
Date: May 8, 2024
Location: Mumbai, MH, IN, 400083
Company: Apotex
About Apotex Inc.
Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group focuses on the development and sale of generic, biosimilar, and specialty products. For more information, visit: www.apotex.com.
Job Summary
Perform all the labelling update activities and tracking in systems for record maintenance with respect to New Product Development (NPD) label creation and Product Life Cycle Management (PLCM) update for products in the USA and Canada markets.
Liaise with various stakeholders (internal/external) to understand any data-related queries or data availability issues on allocated projects. Coordinate with the vendor/affiliates to ensure the timely creation and update of the labels, artwork, and to follow through quality checks of documents prior to submission to regulatory authorities.
Job Responsibilities
- Prepare and update the prescribing information/product monograph and other labeling components as per regulatory requirements for new drug development or product lifecycle maintenance in the US and Canada markets.
- Author, review, and submit responses for labeling deficiencies (e.g., Discipline review letter, Complete response letter, Information request, Clarifaxes) received from regulatory agencies within specified timelines.
- Perform activities in accordance with labeling regulatory guidelines for compliance and drug product safety.
- Liaise and interact with international Apotex affiliates and internal departments to discuss submission strategies and maintain project status.
- Coordinate with artwork vendors for labeling creation and update.
- Initiate and assess change control records (CCR) using QMS.
- Maintain and track projects end to end using RIMS (Regulatory Information Management System) and send status notifications to stakeholders.
- Quality check review and approval of label artworks (e.g., carton, bottle, blister, package insert) in LAMS software (Labeling Artwork Management System) using the BLUE text compare tool.
- Create structured product labeling (SPL), validate and resolve any errors using techniques in LabelBridge software.
- Create, review, and compile regulatory documents for labeling components under eCTD Module-1 using DocuBridge and submit to USFDA/Health Canada via electronic submission gateway (ESG).
- Plan effectively, prioritize, communicate, and deliver quality labeling documents according to company timelines and submission requirements.
- Proofread all types of label copy/annotation/etc. at all development stages as well as final label copy to ensure accuracy of labeling.
- Compile regulatory documents as per USFDA/Health Canada requirements and ensure bookmarking, PDF activity, hyperlinking, and creation of TOC are performed accurately prior to electronic submission to health authorities.
- Undertake continuous learning, development, and training opportunities to enhance skills and career prospects.
- Work collaboratively with the team in accordance with all established regulatory compliance and safety requirements to meet timelines and support and achieve business targets.
- Perform all work in support of the Corporate Values of Courage, Collaboration, Perseverance, and Passion; demonstrates strong and visible support of the company’s values.
- Demonstrate Behaviors that exhibit the company’s organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- Perform other relevant duties as assigned.
Job Requirements
Education:
- M. Pharmacy, B. Pharmacy, or equivalent degree.
Knowledge, Skills, and Abilities:
- Basic knowledge and/or understanding of regulatory requirements for filing labeling submissions in USFDA, Health Canada, or ROW markets.
- Good interpersonal communication skills.
- Demonstrate good writing skills and compilation of submissions.
- Proofreading ability for reviewing technical documents required for dossier preparation.
- Attention to detail to check packaging artwork material and specifications.
- Ability to manage multiple projects/tasks and proactive participation in team-building activities.
- Coordinate with other departments/vendors to ensure timely submission of applications.
- Be accountable for assigned projects and provide prompt responses to queries from various stakeholders or regulatory authorities.
Experience: - Must have labeling experience in any market – US, Canada, Europe, or ROW.
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