Regulatory Affairs Labelling Vacancies Executive | Apotex

Apotex Inc.; Mumbai; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Apotex Inc. is seeking a Regulatory Affairs Labelling Executive based in Mumbai to manage labeling updates for new product developments and lifecycle maintenance in the Canadian market.

You will collaborate with cross-functional teams to ensure timely, accurate labeling for health authorities in Canada, the US, and ROW. Responsibilities include coordinating submissions, preparing supporting documents, and maintaining labeling records, with a focus on regulatory compliance and quality.

Qualifications

• Education: M Pharmacy, B Pharmacy or equivalent.
• Knowledge of US FDA Health Canada or ROW labeling requirements.
• Excellent interpersonal communication skills.
• Strong proofreading and dossier preparation abilities.
• Self-motivated with initiative.

Responsibilities

• Coordinate regulatory submissions and strategies.
• Prepare and submit labeling documents for Canada/US/ROW.
• Coordinate with POC/vendor for artwork creation and updates.
• Maintain labeling tracking records (RIMS, CCR, etc.).
• Update labels for New Drug development or lifecycle maintenance in US/Canada.

Skills

Regulatory knowledge

Attention to detail

Written communication

Team collaboration

Proactive mindset

Education

M Pharmacy

B Pharmacy

Tools

Labelling software

Job description

Apotex Inc. is a Canadian-based global health leader, dedicated to producing high-quality, affordable medicines for patients worldwide. With nearly 7,200 employees across manufacturing, R&D, and commercial operations, Apotex is a significant player in the pharmaceutical industry. The company’s products are available in over 75 countries, focusing on the development and sale of generic, biosimilar, and specialty products.

Job Overview

As a Regulatory Affairs Labelling Executive at Apotex, you will be responsible for managing all labeling updates and maintenance activities for new product developments and product lifecycle maintenance in the Canadian market. This role requires strong collaboration with various teams to ensure the timely creation and submission of accurate labeling materials to health authorities.

Job Responsibilities

• Responsible for coordination & preparation of regulatory submissions and strategies.
• Prepare and submit all the supporting documents for labelling submissions as per the type of submission for Canada Market.
• Co-ordinate with POC/ Vendor for Artwork creation and update.
• Maintain all the tracking requirements for Label update (RIMS, Tracking sheets, CCR, etc.)
• Prepare and update the label/ Monograph as per the requirement in New Drug development or Product lifecycle maintenance in US and Canada market.
• Develop & maintain regulatory knowledge of Canada regulations.
• Manage the final product submissions and negotiate and communicate effectively with regional team/regulatory authorities to obtain timely product approvals.
• Perform ESG submissions and maintain the acknowledgments.
• Author the responses and be a decision maker for the changes applicability in the labels
• Define the priority of the labelling requirements and plan the submission based on priority.
• Maintains user-level knowledge of labelling software’s
• Interacts with other internal departments when necessary.
• Shows initiative to remain current on new labelling regulations and international guidelines and seeks guidance from Leader and management to enhance knowledge.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• 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 labelling submissions in USFDA, Health Canada or ROW markets.
  • Good interpersonal communication skills
  • Demonstrate good writing skills and compilation of submission documents.
  • Proofreading ability for reviewing technical documents required for dossier preparation
  • Attention to detail to check packaging artwork material and specifications
  • Collaborate with team members.
  • Other Techniques: Plant tissue culture (seed germination, Direct-Indirect Organogenesis, Micropropagation), Biochemical assays (Protein estimation, Sugar estimation).
  • Self motivated, taking responsibility and taking initiative.

• Experience:
  • Must have labelling experience in any market – US, Canada, Europe or ROW.

Location

This position is based in Mumbai, Maharashtra (Postal Code: 400083).