Trainee- Labelling, Regulatory Affairs

5 months ago

Mumbai Maharashtra, India Apotex Research Private Limited Full time

**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 is focused on the development and sale of generic, biosimilar and specialty products.

**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 USA and Canada market.

Liaise with various stakeholders (internal/external) to understand any data related queries or data availability issues on allocated projects. Co-ordinate with the vendor/affiliates to ensure the timely creation and update of the labels, artwork and to follow thorough quality check of documents prior to submission to regulatory authorities.

**Responsibilities**:

- 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.

**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 submission
- 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
- 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.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arr

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