Executive, Regulatory Affairs NPD US & Can at Apotex | Apply Now
The Apotex regulatory affairs job offers a rare opportunity for professionals in the regulatory affairs sector. The company is seeking an Executive for Regulatory Affairs NPD US & Can in Mumbai, MH, offering an opportunity to contribute to the preparation and submission of regulatory documents for injectables.
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.
- Date: 16 October 2026
- Location: Mumbai, MH, IN, 400079
- Company: Apotex
Apotex Regulatory Affairs Job Summary
This Apotex regulatory affairs job focuses on preparing and supporting quality submissions for sterile injectable products in the US and Canada.
- 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 in 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 needed.
- 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 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.
Job Requirements
- 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 dossiers 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 commitment to fostering a welcoming and accessible work environment is paramount, ensuring everyone feels valued, respected, and supported to succeed. Accommodation for applicants with disabilities is offered as part of the recruitment process. Applicants for this Apotex regulatory affairs job who are contacted to arrange an interview or testing are advised to inform Apotex if accommodation is required.
This Apotex regulatory affairs job presents a significant opportunity for qualified candidates to make a meaningful impact in the regulatory affairs field. Interested individuals are encouraged to apply before the deadline to secure their consideration for this role.
