Executive Jobs in Pharma: Apotex is Hiring for the position of Executive – Labeling in Mumbai | Apply Now
Apotex, a leading global pharmaceutical company, is inviting applications for the position of Executive, Labeling at its Mumbai location. This full-time, on-site role offers an excellent opportunity for pharmacy professionals to contribute to regulatory labeling processes for new product development and lifecycle maintenance across Canada and international markets. If you have strong attention to detail, labeling experience, and a passion for compliance and innovation, Apotex provides the perfect platform to grow a career in regulatory affairs for those looking for Executive Jobs in Pharma.
Job Details:
- Job Title: Executive, Labeling
- Location: Mumbai
- Job Type: Full-time, On-site
Job Summary
The Executive, Labeling is responsible for all labeling update and maintenance activities related to new product development and product lifecycle management for the Canada market. The role involves coordination with vendors, affiliates, and regulatory contacts to ensure timely creation, update, and submission of product labels as per Health Canada requirements.
About the Company
Apotex Inc. is a Canadian-based global health company committed to improving access to affordable and innovative medicines for millions worldwide. With a vast portfolio of generic, biosimilar, and branded pharmaceuticals, Apotex is the largest Canadian-based pharmaceutical company. Headquartered in Toronto, Apotex operates across regions including the United States, Mexico, and India, serving as a trusted health partner for pharmaceutical licensing and product development.
Education:
M.Pharm or B.Pharm (or equivalent degree).
Experience:
Prior labeling experience in US, Canada, Europe, or ROW markets required.
Key Responsibilities:
- Coordinate and prepare regulatory labeling submissions and supporting documents for the Canada market.
- Collaborate with vendors and affiliates for artwork creation, updates, and approvals.
- Maintain trackers and documentation systems (RIMS, CCR, tracking sheets) to ensure submission timeliness.
- Prepare and update labels and monographs for products in US and Canada markets.
- Develop and maintain regulatory knowledge of labeling standards and submission processes.
- Communicate effectively with regional teams and regulatory authorities to obtain product approvals.
- Perform ESG submissions, author responses, and determine label change applicability.
- Prioritize labeling requirements and plan submissions based on urgency.
- Maintain working knowledge of labeling software and regulatory guidelines.
- Adhere to company values — Collaboration, Courage, Perseverance, and Passion — in all responsibilities.
- Ensure compliance with Global Quality, Safety, Environment, and HR policies.
Knowledge, Skills, and Abilities:
- Basic understanding of regulatory labeling submissions (USFDA, Health Canada, or ROW markets).
- Strong written and verbal communication skills.
- Excellent proofreading and document review ability.
- High attention to detail and accuracy in packaging artwork review.
- Ability to collaborate effectively with cross-functional teams.
- Familiarity with plant tissue culture and biochemical assay techniques is a plus.
- Self-motivated, proactive, and responsible.
