Career in Regulatory Affairs: Trainee Labelling, Regulatory Affairs in Mumbai
Are you a fresh graduate looking to kickstart your career in regulatory affairs? Apotex presents exciting opportunities for trainees in labelling and regulatory affairs in Mumbai. Let's delve into the qualifications, vacancy information, and responsibilities associated with this role.
Subheadings and Paragraphs: About Apotex Inc.: Apotex Inc. is a globally recognized health company dedicated to producing high-quality and affordable medicines worldwide. With a focus on generic, biosimilar, and specialty products, Apotex is committed to improving healthcare accessibility. Job Summary:
- Position: Trainee- Labelling, Regulatory Affairs
- Location: Mumbai, MH, IN, 400083
- To 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 US and Canada market.
- 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.
- Co-ordinate with artwork vendor for labeling creation and update.
- Initiation and assessment of 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 g. carton, bottle, blister, package insert in LAMS software (Labeling Artwork Management System) using 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).
- Effective planning, prioritization, communication and delivery of quality labelling 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, creation of TOC etc, 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 to support and achieve business targets.
- To perform all work in support of our Corporate Values of Courage, Collaboration, Perseverance and Passion demonstrates strong and visible support of our values.
- Demonstrate Behaviours that exhibit our 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.
- All other relevant duties as assigned.
Regulatory Affairs Freshers Vacancies in Mumbai Trainee Labelling[/caption]
Job Requirements: To qualify for this role, you should have:
- A degree in M Pharmacy, B Pharmacy, or equivalent
- Basic knowledge of regulatory requirements in USFDA, Health Canada, or other markets
- Strong communication, writing, and proofreading skills
- Attention to detail and ability to manage multiple projects
- Experience in labelling, preferably in markets like US, Canada, Europe, or ROW
