Executive – Labeling Job in Mumbai | Regulatory Affairs Jobs | Apotex Careers
If you are searching for Regulatory Affairs Jobs, this Executive – Labeling opportunity at Apotex Careers in Mumbai is a great chance to build a rewarding future in pharmaceutical regulatory operations. This role involves labeling updates, regulatory submissions, artwork coordination, lifecycle management, and documentation for Canada and US markets—perfect for experienced pharmacy professionals aiming to excel in regulatory roles.
Job Details
- Job Title: Executive – Labeling
- Location: Mumbai, MH, IN, 400079
About the Company
Apotex is a Canadian-based global health company dedicated to improving access to affordable and innovative medicines for millions worldwide. With a strong presence in India and global operations, Apotex Careers offers excellent Regulatory Affairs Jobs opportunities for talented pharmaceutical professionals.
Job Description
The Executive – Labeling will handle labeling updates, new product development labeling creation, and lifecycle maintenance for products in the Canada Market. The role also includes stakeholder coordination, artwork management, regulatory documentation, compliance tracking, and timely submissions to health authorities.
Key Responsibilities | Regulatory Affairs Jobs
- Coordinate and prepare regulatory submissions and strategies
- Submit supporting documents for Canada labeling submissions
- Coordinate with POC/Vendors for artwork updates
- Maintain RIMS, tracking sheets, CCR, and other regulatory tools
- Prepare and update labels and monographs for the US and Canada
- Maintain knowledge of Canadian regulatory guidelines
- Handle ESG submissions and acknowledgment maintenance
- Support decision-making for label applicability and prioritization
- Work with labeling software and regulatory updates
- Collaborate cross-functionally while maintaining compliance
- Follow quality, HR, and safety compliance guidelines
Qualifications Required for Regulatory Affairs Jobs
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.
