Pharmacy Job at Apotex | Apply Now for the Executive Role
Apotex, a leading global pharmaceutical company, is seeking an experienced Executive, Global Regulatory Affairs to join its team in Mumbai. This Pharmacy Job is crucial for managing the entire Product Life-Cycle Management (PLCM) for Apotex products across major international markets (US, Canada, EU, Australia-NZ). The ideal candidate must have a Post-graduate/Graduate degree in Pharmacy or Life Sciences and a minimum of 3 years of experience compiling quality regulatory submissions, handling post-approval changes, and assessing change control documents to ensure timely global compliance.
- Job Post: Executive, Global Regulatory Affairs
- Location: Mumbai, MH, IN, 400079
About Apotex Inc.
Apotex is a Canadian-based global health company. We improve 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, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
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.
Executive 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.
Executive Job Requirements
- Education: A Post-graduate Pharmacy
- 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.
