Executive, Regulatory Affairs role at Apotex | Pharmacy Graduates Apply
An Apotex regulatory affairs job opportunity has emerged in Mumbai for aspiring professionals. The organization is seeking qualified candidates to fill the Executive position in Regulatory Affairs, focusing on new product development for the US and Canadian markets. Interested individuals are encouraged to 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, it 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.
Job Details
- Date: 17 September 2026
- Location: Mumbai, MH, IN, 400079
- Company: Apotex
Apotex Regulatory Affairs Job Summary
- Preparation of new submissions and deficiency responses to Regulatory agencies (US and Canada) for Injectables (Sterile Dosage Forms).
- Review of quality documents required for regulatory NPD submissions and deficiency responses.
- 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.
Job Responsibilities
- Responsible for the preparation and review of quality regulatory NPD submissions for various markets (US and Canada) to ensure timely approval for Injectables (Sterile Dosage Forms).
- Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets (US and Canada).
- Responsible for review of quality/regulatory documents for new submissions and deficiency responses.
- 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 as part of this regulatory affairs role at Apotex.
- 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 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 and when required.
- Timely communication and follow-up with the respective departments for compilation and filing of submissions and query responses to meet agreed timelines.
- 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 behaviors 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.
Requirements for This Apotex Regulatory Affairs Job
- Education: A Graduate/Postgraduate degree in Chemistry, Biology, Pharmacy, Health Sciences, or similar. Project Management would be an additional advantage.
- Knowledge, Skills, and Abilities:
- Demonstrated knowledge of the generic new product development process/requirements and compilation of dossier for Injectables (sterile) for key markets such as US, Canada, and EU.
- Must possess knowledge of the technical, quality compliance, and global regulatory requirements.
- Excellent communication, presentation, and interpersonal skills.
- Demonstrated experience in influencing & coordinating complex regulatory activities and interaction with cross-functional teams & stakeholders.
- Excellent understanding of Project Management principles and practice in a complex environment.
- Excellent oral/written communication in English.
- Knowledge of and experience with the MS-Office suite of products; with particular emphasis on MS-Word, MS-Excel, and MS-Project (or other PM software).
- Experience: Core Regulatory Affairs. Candidate should have a minimum of 4-7 years of experience in US, Canada, and/or EU.
At Apotex, the organization is committed to fostering a welcoming and accessible work environment, where everyone feels valued, respected, and supported to succeed. They offer accommodation for applicants with disabilities as part of the recruitment process. If contacted to arrange for an interview or testing, applicants are advised to inform if they require an accommodation.
This Apotex regulatory affairs job presents a significant chance for qualified candidates to contribute to a leading global health company. Interested individuals are encouraged to apply before the deadline to seize this opportunity and be part of a team that values innovation and integrity.
