Apotex Hiring Regulatory Senior Analyst/Executive – Labelling

Apotex Inc.; Mumbai; Sur place; INR 1 200 000 - 1 800 000; Plein temps

Résumé du poste

Apotex Inc. is hiring a Senior Analyst/Executive - Labelling in Mumbai to own regulatory labelling activities from development to lifecycle maintenance, with emphasis on Canada and US markets.

The role involves collaborating with internal teams, vendors, and affiliates to ensure compliant, timely submissions. The candidate should have 1–5 years in regulatory affairs, a pharmacy degree, and familiarity with eCTD, DocuBridge, and RIMS.

Qualifications

• 1–5 years of regulatory affairs experience in labelling and submissions.
• Experience with Canada and US regulatory markets is highly preferred.
• Bachelor in pharmacy or related life sciences.
• Strong documentation and submission management skills.

Responsabilités

• Manage labelling updates and maintenance for Canada/US markets.
• Prepare, review, and update product labels and monographs per requirements.
• Coordinate with compilers and vendors to resolve data queries.
• Submit regulatory documents for labelling submissions and maintain timelines.
• Maintain regulatory tracking systems (RIMS, CCR) and dashboards.

Connaissances

Regulatory Affairs

Labelling

eCTD

DocuBridge

RIMS

MS Excel

MS PowerPoint

Submission Management

Formation

M Pharmacy

B Pharmacy

Regulatory Affairs

Pharmaceutical Chemistry

Outils

eCTD

DocuBridge

RIMS

Description du poste

Senior Analyst/Executive - Labelling

M Pharmacy, B Pharmacy Jobs at Apotex Inc | Labelling - Mumbai

Apotex Inc hiring Senior Analyst/Executive - Labelling in Mumbai. M Pharmacy, B Pharmacy eligible. 1-5 years experience required.

Apotex Inc is hiring experienced regulatory professionals for the role of Senior Analyst / Executive - Labelling at its Mumbai location. This opportunity is ideal for pharmacy graduates who want to build a long-term career in regulatory affairs, product labelling, and global pharmaceutical compliance. The role focuses on Canada and US regulatory markets and offers hands-on exposure to new product development, lifecycle management, and health authority submissions in a global pharma environment.

Company Overview

Apotex Inc is a Canada-based global pharmaceutical company known for its strong presence in generic medicines, biosimilars, and innovative branded products. Headquartered in Toronto, Apotex operates across multiple international markets, including the United States, Mexico, and India. It is the largest Canadian-owned pharmaceutical company and a trusted partner for pharmaceutical licensing and product acquisitions across the Americas.

The company's mission is clear. Improve access to affordable, high-quality medicines while maintaining the highest standards of regulatory compliance, quality, and ethics. Apotex has built a solid reputation with global health authorities through consistent adherence to regulatory guidelines, strong pharmacovigilance practices, and robust quality systems. Working at Apotex means contributing directly to healthcare advancement on a global scale.

Job Role & Responsibilities

The Senior Analyst / Executive - Labelling role is a core regulatory affairs position supporting Canada and US markets. The role involves complete ownership of labelling activities from new product development to post-approval lifecycle maintenance.

Key responsibilities include managing label creation, updates, and submissions while ensuring compliance with Health Canada and US regulatory requirements. The professional will work closely with internal teams, vendors, and affiliates to ensure accuracy, timeliness, and regulatory alignment.

Core Responsibilities

• Perform labelling update and maintenance activities for New Product Development and Product Life Cycle Management for Canada and US markets
• Prepare, review, and update product labels and monographs as per regulatory requirements
• Coordinate with compilers to resolve data queries and ensure availability of accurate information
• Follow up on assigned projects to ensure timely completion of labelling deliverables
• Coordinate with vendors and affiliates for artwork creation and updates
• Maintain regulatory tracking systems including RIMS, tracking sheets, CCR, and internal dashboards
• Prepare and submit supporting documents for labelling submissions based on submission type
• Interact with ARPL colleagues and Canada affiliates to address health authority queries
• Author regulatory responses and assess applicability of label changes
• Manage final product submissions and communicate with regional regulatory teams
• Define labelling priorities and plan submissions based on regulatory timelines
• Maintain user-level expertise in labelling and regulatory software systems
• Ensure PM and form checklists are completed by compilers and reviewers to maintain submission quality
• Perform ESG submissions and maintain regulatory documentation
• Stay updated with Canadian labelling regulations and international guidelines
• Train new team members on LAMS software and labelling processes
• Ensure compliance with global quality systems, business ethics, safety, and environmental policies

Eligibility / Qualifications

Candidates must have a strong academic background in pharmacy or related life sciences disciplines along with hands-on regulatory affairs experience.

Required Education

M Pharmacy, B Pharmacy, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Analysis, Pharmacology, Regulatory Affairs, Industrial Pharmacy, Biotechnology, Life Sciences or equivalent degree

Experience Requirement

• 1 to 5 years of relevant experience in Regulatory Affairs, specifically in labelling and submission activities
• Experience with Canada and US regulatory markets is highly preferred

Knowledge, Skills, and Abilities

• Strong experience in compilation of regulatory dossiers using eCTD and DocuBridge
• Knowledge of regulatory submission workflows and labelling requirements
• Working understanding of molecular biology techniques such as PCR, cloning, gel electrophoresis, DNA extraction
• Familiarity with animal assay techniques including dosing and blood withdrawal methods
• Proficiency in MS Excel and PowerPoint for regulatory documentation and tracking
• Strong working knowledge of MS Office, internet tools, and professional email communication
• Excellent written and verbal communication skills
• Strong organizational and presentation abilities
• Ability to manage multiple priorities under strict regulatory timelines

Location & Salary

Job Location: Mumbai, Maharashtra, India

Application Process

Interested and eligible candidates can apply directly through the official job posting link provided by the company. Early applications are recommended due to high response rates.

Apply here: https://www.linkedin.com/jobs/view/4331573714/

Frequently Asked Questions (FAQs)

Q1. Who is eligible to apply for this Apotex labelling role?
Candidates with M Pharmacy or B Pharmacy degrees and 1-5 years of regulatory affairs experience are eligible.

Q2. Is experience in Canada regulatory affairs mandatory?
Experience with Canada or US markets is preferred but not mandatory if the candidate has strong labelling exposure.

Q3. Is this a remote or on-site job?
This is a full-time on-site role based in Mumbai.

Q4. What regulatory tools are required for this role?
Experience with eCTD, DocuBridge, RIMS, and labelling management systems is required.

Q5. Does Apotex provide training for new joiners?
Yes. New joiners receive structured training on LAMS software and internal regulatory processes.