Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc.
Post : Executive, Regulatory Affairs PLCM
Job Description
Job Summary
Responsible for the Electronic Regulatory Submission (ERS) processes. Specifically, accountable for review, publish and validation of eCTD submissions for various markets.
Job Responsibilities
• Reviews the submissions thoroughly and provide guidance to associates in compiling regulatory submissions and fixing the numerous issues occurred thereof.
• Stays current on regulatory guidelines, technical innovations, industry initiatives, and other issues relative to ERS.
• Ensures that all work is performed in full compliance to regulatory and industry directions.
• Contributes to the creation and promotion of an environment of teamwork and empowerment.
• Provides timely and appropriate status reports to Manager as required.
• Provide ESG access to all new user.
• Works as a member of a team to achieve all outcomes.
• Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance, Passion; Demonstrates strong and visible support of our values.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.
Candidate Profile
• Bachelor Degree holder in Pharmacy
• Sound understanding on eCTD, NeeS, CTD, ACTD and paper submission requirements.
• Expertise in one or more eCTD publishing tools and technologies.
• Ability to learn and adapt quickly.
• Ability to manage full workload across multiple projects.
• Excellent verbal and written communication skills.
• 3+ years of experience in publishing.
Additional Information
Experience : 3+ years
Qualification : B.Pharm
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th April, 2024
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