Apotex Hiring for Regulatory Affairs Labelling Executive – apply now
Apotex Inc., a Canadian-based global healthcare giant, is well-known for its commitment to developing high-quality, low-cost medicines for patients all over the world. With almost 7,200 workers split across production, R&D, and commercial operations, Apotex is an important player in the pharmaceutical business. Its goods are offered in over 75 countries, with an emphasis on developing and selling generic, biosimilar, and specialty products. Apotex is looking for a competent and motivated Regulatory Affairs Labeling Executive to join their team in Mumbai.
As an Apotex Regulatory Affairs Labelling Executive, you will be responsible for overseeing labeling updates and maintenance activities for new product development and product lifecycle maintenance, with a focus on the Canadian market. This position requires tight collaboration with several teams to enable the timely preparation and submission of accurate labeling materials to health authorities.
Position Name : Regulatory Affairs Labelling Executive
Organization : Apotex
Qualification: B.Pharm, M.Pharm, Msc, BSc
Experience: 1 to 2 Years
Salary: Not disclosed
Location: mumbai
Key Responsibilities
- Regulatory Submissions and Strategies: Coordinate and prepare regulatory submissions, ensuring that all documents fit the Canadian market’s labeling criteria.
- Document Preparation: Gather and submit supporting documentation for labeling, as well as coordinate with vendors and points of contact to create and update artwork.
- Tracking and Maintenance: Keep track of all label-related tracking needs, such as RIMS, tracking sheets, and CCRs.
- Label updates: Prepare and update labels or monographs to meet new drug development or product lifecycle maintenance standards in the US and Canadian markets.
- Regulatory Knowledge: Stay up to speed on Canadian rules and handle final product submissions, engaging effectively with regional teams and regulatory agencies to ensure timely approvals.
Knowledge, Skills, and Abilities:
- Basic awareness of regulatory requirements for labeling submissions to the US FDA, Health Canada, or other ROW markets.
- Excellent interpersonal and communication abilities.
- Proficient at writing and compiling submission documentation.
- Attention to detail, particularly when reviewing technical documents and packaging artwork.
- Ability to work well with team members.
- Self-motivated having a proactive attitude toward duties and tasks.
- Experience with labeling in any market (US, Canada, Europe, or ROW) is required.
