Join Our Team: Regulatory Affairs Executive Needed at Apotex Inc.-Apply before 20th April, 2024

Apotex Inc
  • Full Time
  • Mumbai

Website Apotex Inc.

About Apotex Inc.

Apotex Inc. is a proudly Canadian pharmaceutical company with a global footprint, dedicated to providing high-quality and affordable medications to patients worldwide. With nearly 8,000 employees spanning various sectors such as manufacturing, research and development (R&D), and commercial operations, Apotex is committed to making a positive impact on global healthcare.

The company’s reach extends to over 100 countries and territories, operating in more than 45 nations, including significant markets in Canada, the United States, Mexico, and India. Through its vertical integration strategy, Apotex comprises multiple divisions and affiliates, each serving distinct purposes in advancing healthcare solutions.

Apotex Inc. primarily focuses on the production of generic medications, ensuring accessibility to essential drugs for diverse patient populations. Additionally, the company’s division, Apobiologix, specializes in the development of biosimilars, contributing to the availability of more affordable biologic treatments. Furthermore, Aveva, an affiliate of Apotex Inc., plays a vital role in supporting the company’s mission through its operations.

With its comprehensive approach to pharmaceutical development, Apotex Inc. continues to uphold its commitment to innovation, accessibility, and patient well-being on a global scale.

Executive – Regulatory Affairs PLCM

Job Description

Job Summary: Responsible for overseeing the product life-cycle management of Apotex products (Toronto) in identified markets, ensuring compliance with regulatory standards. This role involves maintaining documentation and database records, leading regulatory affairs projects, and preparing submission and approval notifications for regulatory agencies.

Job Responsibilities:

  • Support and Guidance: Provide support and regulatory guidance to a team for completing projects related to regulatory submissions.
  • Submission Preparation: Prepare and review quality regulatory post-approval change submissions for various markets to ensure timely approval.
  • Document Maintenance: Maintain regulatory documents to support compliance in various markets and ensure timely completion.
  • Deficiency Response: Coordinate and compile deficiency responses in a timely manner, assessing and resolving issues related to regulatory submissions.
  • Post-Approval Management: Evaluate, prepare, and review post-approval supplements to manage the regulatory product life-cycle effectively.
  • Change Control Assessment: Assess change control documents and provide accurate assessments for assigned changes.
  • Database Maintenance: Maintain regulatory databases and trackers to ensure accuracy of information and compliance with procedures.
  • Supplier Coordination: Coordinate with third-party manufacturers for document requirements for regulatory submissions.
  • Team Support: Act as a backup for team members and provide support as required.
  • Communication: Ensure timely communication and follow-up with departments for compilation and submission of regulatory documents.
  • Compliance: Interpret and ensure compliance with SOPs, RA policies, regulatory guidelines, and draft SOPs and guidelines as needed.
  • Collaboration: Interact with other departments within Apotex to address regulatory issues and provide solutions.
  • External Communication: Communicate with external sources such as agents and suppliers for relevant data.
  • Safety: Work safely and collaboratively as a team member to achieve organizational outcomes.
  • Values Demonstration: Exhibit organizational values of Collaboration, Courage, Perseverance, and Passion.
  • Compliance Adherence: Adhere to all compliance programs and policies including ethics, quality, safety, and HR policies.
  • Other Duties: Perform any other relevant duties as assigned.

Candidate Profile:

  • Post-graduate/Graduate degree in Chemistry/Pharmacy/Life Sciences.
  • Knowledge of post-approval change submission requirements and compilation of variation packages for US/CAN/EU/AUS-NZ/ROW markets.
  • Minimum 3 years of experience in US/CAN/EU/AUS-NZ/ROW markets.

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: 20th April 2024
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