Senior Analyst – Product Life Cycle Management
An Apotex Senior Analyst job opportunity is available in Mumbai for professionals with a background in Chemistry, Pharmacy, or Life Sciences. This role focuses on product life-cycle management, and interested candidates should apply before the deadline.
About The Company
Apotex is a Canadian-based global health company. It improves everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico, and India, Apotex is the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
For more information visit: www.apotex.com.
- Location: Mumbai, MH, IN, 400079
- Company: Apotex
Apotex Senior Analyst Job Summary
- Support in the preparation of new product submissions and responsible for product life-cycle management of Apotex products in the US and Canadian markets.
- Preparation of submission and approval notifications for applications submitted to Regulatory agencies (US and Canada).
- Maintenance of documentation/database records pertaining to approved products in line with systems, processes, and procedures.
Job Responsibilities
- Responsible for the preparation and review of quality regulatory PLCM submissions for various markets (US and Canada) to ensure timely approval. The Apotex Senior Analyst job supports these regulatory submission activities for US and Canada markets.
- Support in preparation of NPD submissions for various markets (US and Canada) to ensure timely approval.
- Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets (US and Canada).
- Prepare pre- and post-approval supplements to manage the regulatory product life-cycle as applicable.
- Assessment of change control documents. Review change control forms and provide an accurate assessment of the change being assessed (as applicable and assigned).
- Maintenance of regulatory databases to ensure accuracy of information. Maintain established trackers (Review checklist for NPD/PLCM/deficiency response, deficiency tracker, submission spreadsheet, etc.) and ensure accuracy of information.
- Co-ordinate 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 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.
- Work in a safe manner, collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit organizational Values: Integrity, Teamwork, Courage, and Innovation.
- Ensure personal adherence to 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.
Eligibility Criteria
Job Requirements:
- Education: A Post-graduate/Graduate degree in Chemistry/ Pharmacy/ Life Sciences.
- Knowledge, Skills and Abilities: Candidate should have knowledge about pre- and post-approval change submission requirements and compilation of new dossier/variation packages for US/CAN/EU/AUS-NZ markets.
- Experience: Candidate should have a minimum of 1 year of experience in US/CAN/EU/AUS-NZ markets.
At Apotex, the organization is committed to fostering a welcoming and accessible work environment, where everyone feels valued, respected, and supported to succeed. Accommodation for applicants with disabilities is offered as part of its recruitment process. If contacted to arrange for an interview or testing, candidates should advise if accommodation is required.
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This Apotex Senior Analyst job presents a significant opportunity for qualified candidates to contribute to the pharmaceutical industry while advancing their careers. Interested individuals are encouraged to apply before the deadline to seize this opportunity.
