Apotex Career: Analyst Role in Mumbai | MSc Chemistry Graduates Apply Now
Are you looking to grow your Chemistry career in the pharmaceutical industry? Apotex has announced an exciting Analyst role in Mumbai under its Global Regulatory Affairs team. This Apotex career opportunity is ideal for candidates with a background in Chemistry, Pharmacy, or Life Sciences who want to build expertise in regulatory product life-cycle management and compliance within a leading global pharmaceutical company.
About ApotexÂ
Apotex is a Canadian-based global health company dedicated to improving access to affordable and innovative medicines worldwide. Headquartered in Toronto with global operations including India, Apotex is the largest Canadian-based pharmaceutical company. An Apotex career offers professionals exposure to international regulatory systems, product life-cycle management, and high-impact pharmaceutical development projects.
- Job Post: Analyst, GBS GRA PLCM
- Location: Mumbai, Maharashtra, India (400079)
- Qualification: A Post-graduate/Graduate degree in Chemistry/ Pharmacy/ Life Sciences or other(s).
- Knowledge, Skills, and Abilities: A candidate should have an understanding of various departments in a pharmaceutical company. A candidate should have an understanding of activities performed by the regulatory affairs department and various software systems used by regulatory professionals.
- Experience:Â Candidate should have a minimum of 1 year of experience in handling various systems used by regulatory professionals.
Job Summary
This Analyst role is responsible for managing product life-cycle activities for Apotex products in identified markets. The position supports regulatory documentation, submission preparation, post-approval changes, and compliance with global regulatory guidelines. This is an exciting opportunity well-suited for candidates seeking to strengthen their Chemistry careers in regulatory affairs.
Job Responsibilities
- Responsible for the preparation of quality post-launch PLCM packages 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 and prepare post-approval supplements to manage the regulatory product life-cycle as applicable.
- Assist in the review of change control documents. Review of change control forms and provide an accurate assessment for the 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.
- Coordinate with third-party manufacturers for document requirements 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 the 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.
- Seeks guidance from other team members to enhance regulatory knowledge.
- Works in a safe manner, collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Integrity, Teamwork, Courage, and Innovation.
- 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.
