Apotex Inc. is a Canadian pharmaceutical company headquartered in Toronto, Ontario. Founded in 1974 by Bernard Sherman, Apotex has become one of the largest generic pharmaceutical companies in the world. They produce a wide range of generic pharmaceutical products covering various therapeutic areas, including cardiovascular, central nervous system, and oncology medications, among others.Apotex has manufacturing facilities in several countries, including Canada, the United States, Mexico, and India. They have a significant global presence, with their products being distributed in over 115 countries.Over the years, Apotex has faced various legal and regulatory challenges, including patent disputes and regulatory issues related to product quality and safety. Despite these challenges, the company has continued to grow and expand its operations globally.Through vertical integration, Apotex focuses on developing and selling generic, biosimilar, and specialty productsVacancy Details
- Position: Trainee – Labelling, Regulatory Affairs
- Department: Regulatory Affairs
- Education: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences, Biomedical Canditates
- Job Lcation : Mumbai
- Experience : 0 Years / Freshers – 1 Years
- Salary : Rs. 22000 Per Month
Job Role Description
Regulatory Strategy and Submissions:
- Developed and executed regulatory strategies for product approvals, ensuring compliance with FDA, EMA, and other global regulatory agencies.
- Prepared and submitted regulatory documents, including INDs, NDAs, BLAs, and MAAs, facilitating timely product approvals.
Compliance and Risk Management:
- Monitored and interpreted regulatory requirements, ensuring company practices and products remained in compliance with evolving regulations.
- Conducted risk assessments and implemented mitigation strategies to address potential regulatory challenges.
Labeling and Documentation:
- Managed the development and approval of product labeling, ensuring accuracy and compliance with regulatory standards.
- Authored and reviewed regulatory documentation, including clinical trial protocols, reports, and safety data summaries.
Regulatory Intelligence and Liaison:
- Maintained up-to-date knowledge of regulatory landscapes and trends, providing strategic insights to guide product development and commercialization.
- Acted as a liaison with regulatory authorities, facilitating clear communication and successful negotiation of regulatory requirements.
Clinical Trial Oversight:
- Supported clinical trial activities by ensuring regulatory compliance, including the preparation and submission of trial applications and amendments.
- Reviewed and approved informed consent forms and other trial documentation to ensure compliance with ethical and regulatory standards.
Job Responsibilities
- Developing strategies for the regulatory approval of new drugs or medical devices, including determining the appropriate regulatory pathways and requirements for different markets.
- Preparing, reviewing, and submitting regulatory documents to health authorities, such as the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in Europe, or Health Canada in Canada. This includes applications for new drug approvals, marketing authorizations, and variations.
- Ensuring that all products and processes comply with relevant regulations, standards, and guidelines. This involves keeping up-to-date with changes in regulations and guidelines and implementing necessary changes within the company.
- Collaborating with Quality Assurance (QA) teams to ensure that manufacturing processes, facilities, and systems meet regulatory requirements for quality and safety.
- Ensuring that product labeling and packaging comply with regulatory requirements, including accurate representation of product information, warnings, and instructions for use.
- Providing regulatory guidance and support for clinical trial planning, conduct, and reporting, including ensuring compliance with Good Clinical Practice (GCP) guidelines.
- Monitoring regulatory developments, trends, and updates to anticipate potential impacts on the company’s products and operations.
- Serving as the primary point of contact for regulatory agencies, responding to inquiries, requests for additional information, and participating in regulatory meetings or audits.
- Assessing and managing regulatory risks associated with product development, approval, and commercialization.
- Collaborating with various internal departments, including Research and Development (R&D), Clinical Development, Manufacturing, Marketing, and Legal, to ensure alignment of regulatory strategies and activities with overall business objectives.
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How to apply
click here to apply – Trainee- Labelling, Regulatory Affairs (apotex.com)