“Join Apotex Inc. as a Regulatory Affairs Executive: M.Pharm, B.Pharm, MSc – Apply Now!”

Apotex Inc
  • Full Time
  • Mumbai

Website Apotex Inc.

About Apotex Inc.

Apotex Inc. is a Canadian pharmaceutical company that takes pride in its global reach, providing high-quality medications at affordable prices to patients worldwide. With a workforce of nearly 8,000 individuals, Apotex operates across various sectors including manufacturing, research and development (R&D), and commercial activities. The company’s products are distributed to over 100 countries and territories, with a presence spanning more than 45 nations, particularly prominent in Canada, the United States, Mexico, and India.

Apotex’s organizational structure reflects its commitment to excellence and innovation through vertical integration. The company consists of multiple divisions and affiliates, each specializing in different aspects of the pharmaceutical industry.

  • Apotex Inc. primarily focuses on the production of generic medications, ensuring accessibility to essential drugs for diverse populations.
  • Apobiologix, a division of Apotex Inc., is dedicated to the development of biosimilars, contributing to the expansion of treatment options and affordability in biologic therapies.
  • Aveva, an affiliate of Apotex Inc., likely engages in complementary activities within the pharmaceutical sector, potentially specializing in areas such as research, distribution, or specialized drug formulations.
  • Executive – Regulatory Affairs, Regulatory Intelligence

    Unlock Your Potential in Regulatory Affairs!

    Job Description

    Job Summary: Join our dynamic team as an Executive in Regulatory Affairs, specializing in Regulatory Intelligence. Your primary responsibilities will include compiling and submitting new registration applications, managing documentation, and supporting regulatory affairs projects. You will play a crucial role in preparing submission and approval notifications for new product applications submitted to regulatory agencies.

    Job Responsibilities:

    • Support the review and compilation of applications for drug products to Health authorities in the US and Canada markets.
    • Compile deficiency packages for assigned products within specified timelines and maintain high-quality standards.
    • Review and compile New Product applications for international markets.
    • Ensure dossier/documents meet internal and regulatory standards, facilitating one-cycle reviews.
    • Assist in compiling supplements/pre-launch variations for assigned products.
    • Maintain accurate records in global regulatory databases and trackers.
    • Handle Electronic Submission Gateway for US & Canada market submissions.
    • Conduct detailed reviews of technical documents for submission and variations.
    • Complete assigned trainings promptly and suggest Key Performance Measures (KPMs).
    • Ensure compliance with SOPs and regulatory guidelines.
    • Act as a backup for team members and support as needed.
    • Provide regulatory support to stakeholders.
    • Demonstrate organizational values and adherence to compliance programs.

    Candidate Profile:

    • Postgraduate/Graduate in pharmacy.
    • Knowledgeable about NPD submission requirements and dossier compilation for US/Canada markets.
    • Minimum 3 years of experience in the US/Canada market.

    Additional Information:

    • Experience: 3 years
    • Qualification: M.Pharm, B.Pharm, M.Sc
    • Location: Mumbai
    • Industry Type: Pharma/ Healthcare/ Clinical Research
    • Functional Area: Regulatory Affairs
    • End Date: 30th April 2024

    If you’re ready to contribute to the global healthcare landscape and thrive in a challenging yet rewarding environment, apply now and take the next step in your regulatory affairs career!

To apply for this job please visit careers.apotex.com.