Executive, Regulatory Affairs PLCm

2 weeks ago

Mumbai, Maharashtra, India Apotex Research Private Limited Full time

About Apotex Inc.
Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

Job Summary:

Responsible for the Electronic Regulatory Submission (ERS) processes. Specifically, accountable for review, publish and validation of eCTD submissions for various markets.

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.

Job Requirements:

  • Education
  • Bachelor Degree holder in Pharmacy
  • Knowledge, Skills and Abilities
  • 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.
  • Experience
  • 3+ years of experience in publishing.


At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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