Home
Communities
Companies
- Companies
  
  Discover best places to work
- Compare Companies
  
  Compare & find best workplace
- Add Office Photos
  
  Bring your workplace to life
- Add Company Benefits
  
  Highlight your company's perks
Reviews
- Company reviews
  
  Read reviews for 6L+ companies
- Write a review
  
  Rate your former or current company
Salaries
- Browse salaries
  
  Discover salaries for 6L+ companies
- Salary calculator
  
  Calculate your take home salary
- Are you paid fairly?
  
  Check your market value
- Share your salary
  
  Help other jobseekers
- Gratuity calculator
  
  Check your gratuity amount
- HRA calculator
  
  Check how much of your HRA is tax-free
- Salary hike calculator
  
  Check your salary hike
Interviews
- Company interviews
  
  Read interviews for 40K+ companies
- Campus placements
  
  Interviews questions for 2K+ colleges
- Share interview questions
  
  Contribute your interview questions
Jobs
Awards

WINNERS AWAITED!
- ABECA 2025
  
  WINNERS AWAITED!
  
  AmbitionBox Employee Choice Awards - 4th Edition
- ABECA 2024
  
  AmbitionBox Employee Choice Awards - 3rd Edition
- AmbitionBox Best Places to Work 2022
  
  2nd Edition
- AmbitionBox Best Places to Work 2021
  
  1st Edition

Add office photos

Engaged Employer

Apotex Research

Compare

4.0

based on 807 Reviews

Video summary

9 Apotex Research Jobs

Executive, Regulatory Affairs PLCM - US/CA/EU

APOTEX PHARMACHEM INDIA PRIVATE LIMITED

4.0

based on 807 Reviews

4-7 years

Mumbai

1 vacancy

Executive, Regulatory Affairs PLCM - US/CA/EU

Apotex Research

posted 3mon ago

Job Role Insights

Flexible timing

Key skills for the job

Regulatory Affairs Recruitment Life Sciences Compliance Product Life Cycle Management Regulatory Compliance

+ 1 more

Job Description

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, RD, 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.
For more information visit: www.apotex.com .

Job Summary

Responsible for the product life-cycle management of Apotex products (Toronto) in identified markets.
Maintenance of documentation/database records pertaining to approved products in line with systems, processes and procedures.
Leading and/or coordinating regulatory affairs projects, as assigned.
Preparation of submission and approval notifications for applications submitted to Regulatory agencies.

Job Responsibilities

Responsible for providing support and regulatory guidance to a team in the completion of projects supporting regulatory submissions.

Responsible for the preparation and review of quality regulatory PLCM submissions for various markets to ensure timely approval.
Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets.
Accountable for assessment, coordination and compilation of deficiency responses in a timely manner.
Works with other functional areas to resolve issues related to information for regulatory submissions.
Evaluate, prepare and review of post-approval supplements to manage the regulatory product life-cycle as applicable.
Assessment of change control documents. Review of change control forms and provide accurate assessment for change being assessed (as applicable and assigned).
Maintenance of regulatory databases to ensure accuracy of information. Maintain established trackers (Review checklist for PLCM/deficiency response, deficiency tracker, submission spreadsheet etc.) and ensure accuracy of information.
Co-ordinate with third party manufacturers for document requirement for regulatory submissions.
Act as a back-up for team members and support as when required.
Timely communication and follow-up with the respective departments for compilation and submission of PLCM submissions and query responses to meet agreed timeline.
Interpret and ensure compliance with SOPs, RA policies procedures and regulatory guidelines. Prepare and/or draft SOPs and regulatory guidelines (as applicable).
Interact with other applicable departments within Apotex to discuss and provide solutions to regulatory issues and/or problems.
Communicate with external sources such as agents and suppliers to request and/or provide data relevant to submissions.
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:
- A Post-graduate/Graduate degree in Chemistry/ Pharmacy/ Life Sciences.

Knowledge, Skills and Abilities:
- Candidate should have knowledge about Post-approval change submission requirement and compilation of variation packages for US/CAN/EU/AUS-NZ/ROW markets.

Experience:
- Candidate should have minimum 3 years of experience in US/CAN/EU/AUS-NZ/ROW markets.

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.

Employment Type: Full Time, Permanent

Read full job description